Company
Linvatec Corp. dba ConMed Linvatec
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
60recalls (0 in 12 months)
17recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HRX | Arthroscope | 17 |
| LXH | Orthopedic Manual Surgical Instrument | 8 |
| KQM | Camera, Surgical And Accessories | 7 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 7 |
| GEY | Motor, Surgical Instrument, Ac-Powered | 3 |
| GCT | Light Source, Endoscope, Xenon Arc | 2 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | 2 |
| HTW | Bit, Drill | 2 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | 2 |
| KDC | Instrument, Surgical, Disposable | 2 |
| FZW | Expander, Surgical, Skin Graft | 1 |
| GBX | Catheter, Irrigation | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 |
| HST | Apparatus, Traction, Non-Powered | 1 |
| HTT | Burr, Orthopedic | 1 |
| HWQ | Passer | 1 |
| JCY | Catheter, Infusion | 1 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2013 | Linvatec Corp. dba ConMed Linvatec ***REF C7122***QTY 1***APEX Arthroscopy Tubing Set.
Intended for use for joint irrigation and dissention during arthroscopic procedures. Terminated |
HRX | K961590 |
| Jul 10, 2013 | Linvatec Corp. dba ConMed Linvatec ***REF C7120***APEX Arthroscopy Tubing Set.
Intended for use for joint irrigation and dissention during arthroscopic procedures. Terminated |
HRX | K954440 |
| Jul 1, 2013 | Linvatec Corp. dba ConMed Linvatec GENESYS Cross FT Suture Anchor with Two #2 (5 metric) Hi-FI Registered Trade Mark Sutures Rx Only STERILE EO CONMED LINVATEC REF CFBC-4502.
Reattachment of soft tissue to bone in orthopedic surgical Terminated |
MAI | K101100 |
| May 20, 2013 | Linvatec Corp. dba ConMed Linvatec Ref: VP1600 HD Still Capture System ConMed Linvatec .
Captures, stores and transfers images generated by a medical endoscopic camera system during surgical procedures. Terminated |
KQM | None listed |
| Mar 6, 2013 | Linvatec Corp. dba ConMed Linvatec D3000I Advantage Drive System, 230v, surgical instrument motor.
Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perfor Terminated |
GEY | K050519 |
| Mar 6, 2013 | Linvatec Corp. dba ConMed Linvatec D3000 Advantage Drive System, 115v
Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and Terminated |
GEY | K050519 |
| Feb 5, 2013 | Linvatec Corp. dba ConMed Linvatec ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm
Orthopedic manual surgical instrument - Bone Punch Terminated |
LXH | None listed |
| Nov 19, 2012 | Linvatec Corp. dba ConMed Linvatec "***SENTINEL***Cannulated Drill Bit***S8585***8.5 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2009-02***".
This drill bit is an eccentric mono-fluted cutting ed Terminated |
HTW | None listed |
| Nov 19, 2012 | Linvatec Corp. dba ConMed Linvatec "***SENTINEL***Cannulated Drill Bit***S8580***8 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2012-03***".
This drill bit is an eccentric mono-fluted cutting edge Terminated |
HTW | None listed |
| Oct 29, 2012 | Linvatec Corp. dba ConMed Linvatec "***All in one CrossFT***Punch***PFT-00M***4.5mm to 6.5mm***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***"
To create pathway for insertion of CrossFT Suture Anchor into bone. Terminated |
LXH | None listed |
| Oct 15, 2012 | Linvatec Corp. dba ConMed Linvatec NP211H***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***
To reattach soft tissue to bone in orthopedic surgical procedures Terminated |
MBI | K112965 |
| Oct 15, 2012 | Linvatec Corp. dba ConMed Linvatec "***PressFT***2.1 w/ One #2 (5 metric) Hi-Fi***Suture***NP211***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***
To reattach soft tissue to bone in orthopedic surgical procedu Terminated |
MBI | K112965 |
| Oct 15, 2012 | Linvatec Corp. dba ConMed Linvatec "***PressFT***2.1 w/ Two #0 (3.5 metric) Hi-Fi***Sutures***NP212***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***
To reattach soft tissue to bone in orthopedic surgical proc Terminated |
MBI | K112965 |
| Oct 15, 2012 | Linvatec Corp. dba ConMed Linvatec "***Press FT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture, HIP***N2***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***
To reattach soft tissue to bone in orthopedic surgical proc Terminated |
MBI | K112965 |
| Oct 15, 2012 | Linvatec Corp. dba ConMed Linvatec "***PressFT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture***NP261***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***
To reattach soft tissue to bone in orthopedic surgical procedu Terminated |
MBI | K112965 |
| Oct 15, 2012 | Linvatec Corp. dba ConMed Linvatec "***PressFT***2.6 w/ Two #1 (4 metric) Hi-Fi***Sutures***NP262***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***
To reattach soft tissue to bone in orthopedic surgical proced Terminated |
MBI | K112965 |
| Sep 27, 2012 | Linvatec Corp. dba ConMed Linvatec Catheter Irrigation Set labeled in part: ***24K Arthroscopy Outflow/Suction Tubing Set***
This Arthroscopy Tubing Set is intended for use, in conjunction with the ConMed Linvatec 24k Pump, for pump-i Terminated |
GBX | None listed |
| Sep 25, 2012 | Linvatec Corp. dba ConMed Linvatec ***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light Source Terminated |
GCT | K070376 |
| Sep 25, 2012 | Linvatec Corp. dba ConMed Linvatec ***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source Terminated |
GCT | K070376 |
| Aug 6, 2012 | Linvatec Corp. dba ConMed Linvatec PopLok Punch labeled in part:
"PKL-35M***3.5mm***QTY 1***PopLok Punch***ConMed Linvatec Biomaterials, Ltd. Hermiankatu 6-8L 33720 Tampere, FINLAND***Rx Only***ConMed Linvatec 11311 Concept Blvd Largo, Terminated |
LXH | None listed |
| Aug 6, 2012 | Linvatec Corp. dba ConMed Linvatec CrossFT Punch, Product Number PFT-45M. Manufacturer: CONMED LINVATEC. The intended use is to create a hole to facilitate insertion of the CrossFT suture anchor into bone. Terminated |
LXH | None listed |
| Feb 10, 2012 | Linvatec Corp. dba ConMed Linvatec ***REF C9944A***"FULL RADIUS RESECTOR"***2.9mm***Qty 6***STERLING***STERILE***Rx Only.*** Made in the USA***Manufacturer: CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***ConMed Linvatec Terminated |
GFA | None listed |
| Jun 29, 2011 | Linvatec Corp. dba ConMed Linvatec "***LINVATEC SRS SHOULDER RESTORATION SYSTEM CrossFT 5.5mm CrossFT Suture Anchor with Two#2 (5 metric) Hi-Fi Sutures***SRS.Linvatec.com***ConMed Linvatec Biomaterials, Ltd. Hemiankatu 6-8L 33720 Tampe Terminated |
MBI | None listed |
| Apr 5, 2011 | Linvatec Corp. dba ConMed Linvatec ***REF VP6528***Qty 1***Articulating Arm, Secondary Flat Panel***RX Only***See Instructions for Use***CONMED LINVATEC, CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA***
Catalog No Terminated |
KQM | None listed |
| Apr 4, 2011 | Linvatec Corp. dba ConMed Linvatec POUCH/CARTON LABEL:
***REF 5023-138***9.5 x 25.5 x 0.4mm***QTY 1***MICRO SAGITTAL BLADE, FINE***STERILE***Rx Only***CONMED LINVATEC, CONMED LINVATEC 11211 CONCEPT BLVD LARGO, FL 33773-4908 USA***Mad Terminated |
HWE | None listed |
| Mar 25, 2011 | Linvatec Corp. dba ConMed Linvatec ***REF 24k100***QTY 1***24k Arthroscopy Outflow/Suction Tubing Set***MADE IN USA***Rx Only***CONMED LINVATEC, CONMED LINVATEC 11311 CONCEPT BLVD, LARGO, GL 33773-4900***
For use in conjunction with t Terminated |
JCY | None listed |
| Jan 4, 2011 | Linvatec Corp. dba ConMed Linvatec Video Cart, 120 VAC product labeling is as follows:
REF, VP8500, QTY1, Video Cart, 120 VAC, Rx ONLY.
These Video Carts are intended for storage of Endoscopic equipment that is used in single or mu Terminated |
KQM | None listed |
| Jan 4, 2011 | Linvatec Corp. dba ConMed Linvatec Video Cart Articulating Arm product labeling is as follows:
REF, VP6504, QTY1, Video Cart Articulating Arm, Rx ONLY,
These Video Carts are intended for storage of Endoscopic equipment that is used in Terminated |
KQM | None listed |
| Jan 4, 2011 | Linvatec Corp. dba ConMed Linvatec Video Cart Multi-Specialty product labeling is as follows:
REF, VP6502, QTY1, Video Cart Multi-Specialty, 120V, Rx ONLY,
These Video Carts are intended for storage of Endoscopic equipment that is use Terminated |
KQM | None listed |
| Jan 4, 2011 | Linvatec Corp. dba ConMed Linvatec Video Cart, Premium 120V product labeling is as follows:
REF, VP6501, QTY1, Video Cart, Premium, 120V, Rx ONLY.
These Video Carts are intended for storage of Endoscopic equipment that is used in singl Terminated |
KQM | None listed |
| Jan 4, 2011 | Linvatec Corp. dba ConMed Linvatec The Power Cord Reel is labeled as follows:
REF, VP6547, QTY1, POWER CORD REEL, Rx ONLY.
These Video Carts are intended for storage of Endoscopic equipment that is used in single or multiple surgical Terminated |
KQM | None listed |
| Sep 28, 2010 | Linvatec Corp. dba ConMed Linvatec CONCEPT GRAFIX TENDON STRIPPER. REF TS8850. 7.0MM, QTY 1. Rx Only, Non-Sterile, Made In USA. Terminated |
FZW | None listed |
| Sep 25, 2010 | Linvatec Corp. dba ConMed Linvatec GATOR. REF 9263A, 4.2mm STERLING, STERILE Rx Only. Terminated |
GFA | None listed |
| Aug 24, 2010 | Linvatec Corp. dba ConMed Linvatec REF 70-0078-103, 3mm ARTHRO-KNIFE SHEATHED KNIFE, SERRATED, STRAIGHT, 2-SIDED, ROUND, STERILE, Rx ONLY.
CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA. Terminated |
HRX | None listed |
| Aug 24, 2010 | Linvatec Corp. dba ConMed Linvatec REF 70-0077-103, 3mm ARTHRO-KNIFE SHEATHED KNIFE, SERRATED, STRAIGHT, 2-SIDED, STERILE, Rx ONLY.
CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.
Intended for use in orthaepedic su Terminated |
HRX | None listed |
| Aug 24, 2010 | Linvatec Corp. dba ConMed Linvatec REF 70-0076-003, 3mm ARTHRO-KNIFE SHEATHED KNIFE, CRESCENT, STRAIGHT, STERILE, Rx ONLY.
CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.
Intended for use in orthaepedic surgery wher Terminated |
HRX | None listed |
| Aug 24, 2010 | Linvatec Corp. dba ConMed Linvatec REF 70-0075-003, 3mm ARTHRO-KNIFE SHEATHED KNIFE, MINI-MENISCUS, STRAIGHT, STERILE, Rx ONLY.
CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.
Intended for use in orthaepedic surgery Terminated |
HRX | None listed |
| Aug 24, 2010 | Linvatec Corp. dba ConMed Linvatec REF 70-0074-103, 3mm ARTHRO-KNIFE SHEATHED KNIFE, ROSETTE, SERRATED, STRAIGHT, STERILE, Rx ONLY.
CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.
Intended for use in orthaepedic sur Terminated |
HRX | None listed |
| Aug 24, 2010 | Linvatec Corp. dba ConMed Linvatec REF 70-0073-003, 3mm ARTHRO-KNIFE SHEATHED KNIFE, RETRO, STRAIGHT, STERILE, Rx ONLY.
CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.
Intended for use in orthaepedic surgery where a Terminated |
HRX | None listed |
| Aug 24, 2010 | Linvatec Corp. dba ConMed Linvatec REF 70-0072-003, 3mm ARTHRO-KNIFE SHEATHED KNIFE, HOOK, STRAIGHT, STERILE, Rx ONLY.
CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.
Intended for use in orthaepedic surgery where a Terminated |
HRX | None listed |
| Aug 24, 2010 | Linvatec Corp. dba ConMed Linvatec REF 70-0071-113, 3mm ARTHRO-KNIFE SHEATHED KNIFE, BANANA, SERRATED LEFT, STERILE, Rx ONLY.
CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.
Intended for use in orthaepedic surgery w Terminated |
HRX | None listed |
| Aug 24, 2010 | Linvatec Corp. dba ConMed Linvatec REF 70-0071-103, 3mm, ARTHRO-KNIFE SHEATHED KNIFE, BANANA, SERRATED STRAIGHT, STERILE, Rx ONLY.
CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.
Intended for use in orthopaedic surg Terminated |
HRX | None listed |
| Aug 24, 2010 | Linvatec Corp. dba ConMed Linvatec REF C4000 INTEQ TFCC SMALL JOINT SUTURING SYSTEM KITS, STERILE, Rx ONLY.
CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA. Terminated |
HRX | None listed |
| Aug 24, 2010 | Linvatec Corp. dba ConMed Linvatec C-REAMER CANNULATED, STERILE, Rx ONLY.
REF 8772A, 9.0MM, QTY DIST 712.
REF 8773A, 10MM, QTY DIST 1,244.
REF 8774A, 11MM, QTY DIST 384
REF 8775A, 12MM, QTY DIST 156
CONMED LINVATEC, 11311 CONC Terminated |
LXH | None listed |
| Aug 24, 2010 | Linvatec Corp. dba ConMed Linvatec REF, 9973, 2.4mm ARTHROSCOPY KNIFE, BANANA STYLE, SMALL JOINT, STERILE, Rx ONLY.
CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.
Intended for proper tissue dissection in small join Terminated |
HRX | None listed |
| Aug 24, 2010 | Linvatec Corp. dba ConMed Linvatec REF 9906, DIGIT TRAP FINGER GRASPING DEVICE, STERILE.
CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.
Intended for use in small joint arthroscopic procedures. Terminated |
KDC | None listed |
| Aug 24, 2010 | Linvatec Corp. dba ConMed Linvatec REF 9903, DIGIT TRAP FINGER GRASPING DEVICE, LARGE STERILE.
CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.
Intended for use in small joint arthroscopic procedures. Terminated |
KDC | None listed |
| Aug 24, 2010 | Linvatec Corp. dba ConMed Linvatec REF 8788, 8mm C-REAMER, CANNULATED, STERILE, Rx ONLY.
CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.
Intended for use in Arthroscopic knee procedures. Terminated |
LXH | None listed |
| Aug 24, 2010 | Linvatec Corp. dba ConMed Linvatec REF 8787, 7mm C-REAMER, CANNULATED, STERILE, Rx ONLY.
CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.
Intended for use in Arthroscopic knee procedures. Terminated |
LXH | None listed |
| Aug 24, 2010 | Linvatec Corp. dba ConMed Linvatec REF 8586, 6mm C-REAMER, CANNULATED, STERILE, Rx ONLY.
CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.
Intended for use in Arthroscopic knee procedures. Terminated |
LXH | None listed |
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