Company ยท US
Linvatec Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 2009. Name variants (Inc, Corp, punctuation) are merged.
93510(k) clearances (0 in 12 months)
56recalls (0 in 12 months)
7recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GET | Motor, Surgical Instrument, Pneumatic Powered | 47 |
| HRX | Arthroscope | 20 |
| HWC | Screw, Fixation, Bone | 17 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 11 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 10 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 6 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 5 |
| GCJ | Laparoscope, General & Plastic Surgery | 4 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 4 |
| GEY | Motor, Surgical Instrument, Ac-Powered | 3 |
| JOS | Electrode, Electrosurgical | 3 |
| DZI | Drill, Bone, Powered | 2 |
| HBC | Motor, Drill, Electric | 2 |
| FHO | Pneumoperitoneum Needle | 1 |
| GCT | Light Source, Endoscope, Xenon Arc | 1 |
| GDW | Staple, Implantable | 1 |
| GFF | Bur, Surgical, General & Plastic Surgery | 1 |
| HAB | Saw, Powered, And Accessories | 1 |
| HET | Laparoscope, Gynecologic (And Accessories) | 1 |
| HIG | Insufflator, Hysteroscopic | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 23, 2009 | K092998 | CONMED LINVATEC INTERCEPT IMPLANT Linvatec Corp. | MBI |
| Jun 23, 2009 | K091549 | CONMED LINVATEC SOFT TISSUE TO BONE SYSTEM Linvatec Corp. | MBI |
| Jun 22, 2009 | K090835 | CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CR Linvatec Corp. | MAI |
| Apr 10, 2009 | K090186 | CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURES Linvatec Corp. | MAI |
| Feb 25, 2009 | K083281 | EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUCTION ABLATOR, MODEL IA-2000-S, LIGHTWAVE ABLATOR, MODEL IA- Linvatec Corp. | GEI |
| May 11, 2006 | K060198 | MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND OSCILLATING SAW Linvatec Corp. | HRX |
| Apr 10, 2006 | K060270 | MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL Linvatec Corp. | DZI |
| Apr 10, 2006 | K060260 | MICROPOWER HAND PIECE HIGH SPEED DRILL Linvatec Corp. | HBC |
| May 17, 2005 | K050519 | ADVANCED TURBO DRIVE SYSTEM Linvatec Corp. | GEY |
| Mar 25, 2005 | K050497 | BIOSCREW XTRALOK, 8X35MM & 8X40MM VIOLET Linvatec Corp. | HWC |
| Mar 2, 2005 | K050227 | THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER Linvatec Corp. | MBI |
| Jan 19, 2005 | K043106 | PINN-ACL CROSSPIN Linvatec Corp. | HTY |
| Nov 4, 2004 | K042778 | BIOANCHOR WITH DISPOSABLE DRIVER, PRELOADED WITH ONE #2 HERCULINE SUTURE Linvatec Corp. | HWC |
| Jul 29, 2004 | K041128 | SUTURE ARROW Linvatec Corp. | MAI |
| Jul 22, 2004 | K041713 | SUPER REVO HERCULINE SUTURE ANCHOR Linvatec Corp. | MBI |
| Feb 11, 2004 | K033573 | LINVATEC 10K IRRIGATION SYSTEM Linvatec Corp. | HRX |
| Dec 31, 2003 | K033804 | BIOANCHOR WITH DISPOSABLE DRIVER Linvatec Corp. | HWC |
| Dec 15, 2003 | K033748 | TRIDENT RESECTION ABLATOR Linvatec Corp. | GEI |
| Nov 10, 2003 | K032607 | POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185 Linvatec Corp. | DZI |
| Aug 21, 2003 | K031994 | LINVATEC 300W XENON LIGHT SOURCE Linvatec Corp. | GCT |
| Jun 4, 2003 | K031098 | 3-CCD DIGITAL CAMERA SYSTEM Linvatec Corp. | GCJ |
| Jun 3, 2003 | K030720 | ULTRABLATOR ELECTRODE Linvatec Corp. | GEI |
| Nov 22, 2002 | K022827 | ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR Linvatec Corp. | MBI |
| Jun 11, 2002 | K013131 | BIOSCREW XTRALOK Linvatec Corp. | HWC |
| May 6, 2002 | K020377 | PRE-LOADED BIOSTINGER HORNET Linvatec Corp. | HWC |
| Apr 4, 2002 | K013369 | RESECTION ABLATOR Linvatec Corp. | GEI |
| Dec 19, 2001 | K013553 | PRE-LOADED ULTRAFIX RC Linvatec Corp. | MBI |
| Nov 29, 2001 | K013117 | RESECTION ABLATOR Linvatec Corp. | HRX |
| Oct 19, 2001 | K012320 | POWERPRO BATTERY SYSTEM Linvatec Corp. | HAB |
| Mar 19, 2001 | K003984 | SUPER REVO SUTURE ANCHOR Linvatec Corp. | MAI |
| Mar 6, 2001 | K002088 | SHAVER ABLATOR Linvatec Corp. | HRX |
| Oct 6, 2000 | K002523 | ADVANTAGE DRIVE SYSTEM Linvatec Corp. | HBC |
| Feb 10, 2000 | K993885 | ULTRABLATOR ELECTRODE Linvatec Corp. | JOS |
| Dec 10, 1999 | K993339 | ENDOPEARL WITH THREADER Linvatec Corp. | MAI |
| Nov 16, 1999 | K991024 | BONE BULLET SUTURE ANCHOR Linvatec Corp. | HWC |
| Sep 17, 1999 | K990194 | BIOBUTTON Linvatec Corp. | HWC |
| Aug 20, 1999 | K991830 | CAPSULAR SHRINKAGE ELECTRODE Linvatec Corp. | JOS |
| Aug 6, 1999 | K991715 | BIOSTINGER-V BIOABSORBABLE MENISCAL REPAIR DEVICE Linvatec Corp. | MAI |
| Jul 30, 1999 | K990770 | BIORC ANCHOR Linvatec Corp. | HWC |
| Jul 15, 1999 | K990524 | E9000 SYSTEM Linvatec Corp. | HRX |
| Apr 29, 1999 | K984171 | ENDOPEARL Linvatec Corp. | MAI |
| Mar 23, 1999 | K983652 | ABLATOR ELECTRODE Linvatec Corp. | HRX |
| Oct 21, 1998 | K983186 | BIO-ANCHOR, PRE-LOADED BIOABSORBABLE SUTURE ANCHOR Linvatec Corp. | MAI |
| Aug 20, 1998 | K981636 | INTEGRATED DRIVE/PUMP SYSTEM Linvatec Corp. | HRX |
| Jul 27, 1998 | K981692 | MENISCAL REPAIR DEVICE Linvatec Corp. | MBI |
| Jul 20, 1998 | K981637 | INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY Linvatec Corp. | ERL |
| Jun 24, 1998 | K981269 | UNIVERSAL DRIVE SYSTEM Linvatec Corp. | HRX |
| Mar 3, 1998 | K974538 | MENISCAL REPAIR DEVICE Linvatec Corp. | HWC |
| Feb 27, 1998 | K973758 | BIOSCREW ABSORBABLE INTERFERENCE SREW Linvatec Corp. | HWC |
| Jun 20, 1997 | K963932 | PRELOADED SOFT TISSUE ANCHOR Linvatec Corp. | MBI |
Newest 50 of 93.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile THIN X-FINE, Catalog # L135
ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or large bone orthopedic surgeries. These bla Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile STERILE REPL BLD/STRYKER, Catalog # 00507219500
ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or large bone orthopedic su Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile STERILE ACL BLD, Catalog # 00502318200, 00502318300, and 00502318400.
ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or la Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile STER RPLCMNT BLADE/STRYKER RECIP, Catalog # 00505213500
ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or large bone orth Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile STER REPT STERNTMY BLD, Catalog # 00507122800
ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or large bone orthopedic surge Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile STER OSC BLD, Catalog # 00507118000, 00507118700, 00507118800, 00507118500,
00507118100, 00507118400, 00507112300, 00507112400, and 00507118600.
ConMed Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile ST STERNUM SAW BLADES, Catalog # 00505953200
ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or large bone orthopedic surge Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile ST SAGITTAL BLD FINE, Catalog # 00502324500 and 00502324700.
ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or large bone Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile ST SAG/OSC BLADE, Catalog # 00505928200, 00505928300, 00505928400, and 00138417700.
ConMed Linvatec Hall (R) Surgical Blades are intended for use in sm Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile ST SAG BLADE, Catalog # 00502314400, 00502313900, 00502314100, 00502311800,
00502313800, 00502314000, and 00502312800.
ConMed Linvatec Hall (R) Surgica Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile ST SAG BLDE CRS, Catalog # 00502313300, 00502313700, 00502313000, 00502313100, 00502313500, 00502313200, and 00502314300.
ConMed Linvatec Hall (R) Surg Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile ST SAG BLD FN 70D, Catalog # 00502312900
ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or large bone orthopedic surgeries Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile ST REPL STRYKER SAG, Catalog # 00507215200, 00507215800, 00507215000, 00507210900,
00507210500, 00507211100, 00507215100, 00507210200, 00507210000
005072 Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile ST REPL BLADE/STRYKER RECIP, Catalog # 00505233400, 00505233200, 00505923500, 00507210100,
00507218100, and 00505331100.
ConMed Linvatec Hall (R) Surgi Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile ST REPL BLADE/SARNS STERNUM SAW, Catalog # 00505923300
ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or large bone orthop Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile ST REPEAT STERN BLADE, Catalog # 00502317900, 00502318800, 00502318700, 00505927800, and 00505927900.
ConMed Linvatec Hall (R) Surgical Blades are inte Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile ST RECIPROCATOR BLADE, Catalog # 00505217300
ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or large bone orthopedic surge Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile ST OSCIL BLD,ME-92 COATED, Catalog # 00507116600
ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or large bone orthopedic Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile ST OSCIL BLD, Catalog # 00507157200, 00507155400, and 00507155500.
ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or large Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile ST OSCIL BLADE, ME-92 COAT, Catalog # 00507117700, 00507117800, and 00507119500.
ConMed Linvatec Hall (R) Surgical Blades are intended for use in small Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile ST OSC BLDE, Catalog # 00507155200, 00507155300, 00507114600, 00507155100, 00507155600, 00507155000, 00507112500, 00507112600, and 00507112700.
ConMed Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile ST OSC BLDE RADSD, Catalog # 00502316500
ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or large bone orthopedic surgeries. Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile ST OSC BLDE FINE, Catalog # 00502316100, 00502316300, 00502316900, 00502316600, 00502316000, 00502316200, and 00502316400.
ConMed Linvatec Hall (R) Sur Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile ST OSC ABRASION BLADE, Catalog # 00507117500, 00507114100, 00507116700, 00507114000, 00507114300, 00507114200, and 00507114400.
ConMed Linvatec Hall (R Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile ST OSC BLD, Catalog # 00507114500, 00507113200, 00507117400, 00507116300, 00507113300, and 00507113400.
ConMed Linvatec Hall (R) Surgical Blades are int Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile ST MICRO RECIP SAW BLADES, Catalog # 00505312200, 00505322100, and 00505322000.
ConMed Linvatec Hall (R) Surgical Blades are intended for use in small Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile ST MICRO OSCILLSAW BLADE, ANG, Catalog # 00505327700
ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or large bone orthopedi Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile ST EXTENDED STERNUM SAW BLADES, Catalog # 00505953100.
ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or large bone ortho Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile ST BLD BRZL NEXGEN, Catalog #00507120100
ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or large bone orthopedic surgeries. Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile ST ACL BLADE, Catalog # 00502318500 and 00502318600.
ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or large bone orthoped Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile Catalog
ADVANCED CUT SAG SAW BLD, Catalog # C8902 and C8904.
ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or large bone Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile SAGITTAL SAW BLADE THIN, Catalog # K132, K133, K134, and K135.
ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or large bone Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile SAGITTAL SAW BLADE, Catalog # K121, K141, K142, K143, K144, K146, K147, K148, K151, K152, K153, K154, K155, and K156.
ConMed Linvatec Hall (R) Surgica Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile SAG BLADE Bent or Angled, Catalog # U335, U332, and U438.
ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or large bone or Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile REPEAT STERNOTOMY BLADE, Catalog # 00502317800
ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or large bone orthopedic surg Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile RECIPROCATOR BLADE, Catalog # 00505226000, 00505226100, 00505225900, 00505217900, 00505225800, and 00505227600.
ConMed Linvatec Hall (R) Surgical Blad Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile RECIP SAW BLADE, Catalog # U773 and P513
ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or large bone orthopedic surgeries Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile OSCILLATING KNEE BLADE, Catalog # L192 and L197
ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or large bone orthopedic su Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile OSCBLD, Catalog # 00507158900 and 00507156400
ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or large bone orthopedic surg Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile OSC SAW BLAD, Catalog # L121, L122, L145, L146, L124, L130, and L129.
ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or l Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile OSC BLADE, Catalog # 00507116100 and 00507158200.
ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or large bone orthopedic Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile MICRO SAG SAW BLADE FINE, Catalog # 00502313400, 00502324900, 00505303350, and 00504414500.
ConMed Linvatec Hall (R) Surgical Blades are intended for Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile MAX DRV OSC BLD, Catalog # 00507318100.
ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or large bone orthopedic surgeries Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile LG BONE OSC BLADE, Catalog #00507154800, 00507154700, 00507123600, 00507155700, 00507155800, 00507159000, and 00507157100.
ConMed Linvatec Hall (R) Sur Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile INTEX BLADE, Catalog #
00507132000, 00507134000, 00507135300, 00507135400, 00507135600, 00507130000, 00507130300, 00507130400, 00507130500, 00507131400, Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile FREE HAND SAW BLADE MICRO CHOICE, Catalog # C8804, C8802, and C8806.
ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or l Terminated |
GET | None listed |
| Jan 15, 2009 | Linvatec Corp. ConMed Linvatec Hall Surgical Blades, Sterile OSC/SAG BLADE, Catalog # U655, U554, and U551.
ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or large bone orthopedic sur Terminated |
GET | None listed |
| Apr 8, 2008 | Linvatec Corp. ConMed Linvatec, Ultrapower Burs, Linvatec Corporation, Largo, FL 33773 Terminated |
GFF | K781979 |
| Nov 16, 2006 | Linvatec Corp. ConMed Linvatec Sternum Saw Collet Nut, Catalog Number 5059-09: Used on ConMed Linvatec Sternum Saw Handpieces (ConMed Linvatec, Hall. Versipower, Versipower Plus Handpieces) and sold individually. Terminated |
KFK | None listed |
| Aug 29, 2006 | Linvatec Corp. ConMed Linvatec MicroChoice Footswitch and ConMed linvatec 3 Pedal Footswitch. Used to operate various surgical handpieces. Terminated |
GEY | None listed |
Newest 50 of 56.