Panels › Orthopedic › Product code LXH · Class 1
Orthopedic Manual Surgical Instrument
Regulation 888.4540
0510(k)s in 12 months (58 all time)
8recalls in 12 months (526 all time)
20recalls that name a 510(k)
Top companies in LXH
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 22, 2011 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, Tendon Stripper, Slotted, 5.0 mm I.D. x
12 working length. Non-Sterile
Catalog Number: 013554
Orthopedic Manual Surgical Instrument Terminated |
LXH | None listed |
| Aug 1, 2011 | Biomet Microfixation, Inc. "***BIOMET MICROFIXATION***CENTER DRIVE STAINLESS STEEL***2.0MM SYSTEM SCREWDRIVER BLADE***Non-Sterile Product***BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofix Terminated |
LXH | None listed |
| Jun 30, 2011 | Biomet, Inc. Comprehensive Shoulder Instruments Fracture Stem Inserter w/Version Control, REF 31-406901, Biomet Orthopedics Warsaw, IN, Instrument used to introduce the stem into the canal.
The instrument is used Terminated |
LXH | None listed |
| Jun 30, 2011 | Biomet, Inc. Comprehensive Shoulder Instruments Primary Shoulder Stem Inserter, REF 407398, Biomet Orthopedics Warsaw, IN, Instrument used to introduce the stem into the canal.
The instrument is used to insert th Terminated |
LXH | None listed |
| Mar 22, 2011 | Depuy Orthopaedics, Inc. AFFIXUS Lag Screw Drill, REF 2112-01-303, Non-Sterile, DePuy Orthopaedics, Inc., Warsaw, IN; DePuy International Leeds, England. Terminated |
LXH | K100238 |
| Mar 16, 2011 | Stryker Howmedica Osteonics Corp. SCORPIO-FLEX CR TIBIAL TRIAL, non sterile, made in the USA
Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430.
The Tibial trial are utilized during surgery to assess the overall compone Terminated |
LXH | None listed |
| Mar 16, 2011 | Stryker Howmedica Osteonics Corp. SCORPIO-FLEX PS TIBIAL TRIAL, non sterile, made in the USA
Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430.
The Tibial trial are utilized during surgery to assess the overall compon Terminated |
LXH | None listed |
| Mar 16, 2011 | Stryker Howmedica Osteonics Corp. SCORPIO PS TIBIAL TRIAL, non sterile, made in the USA
Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430.
The Tibial trial are utilized during surgery to assess the overall component f Terminated |
LXH | None listed |
| Feb 22, 2011 | Depuy Orthopaedics, Inc. S-ROM Distal Femoral Cutting block Guide SZ MED, REF 216311004, non-sterile, Depuy International Leeds, England.
The product is used to make cuts in the femur to prepare the femur for total knee rep Terminated |
LXH | None listed |
| Feb 22, 2011 | Depuy Orthopaedics, Inc. S-ROM Distal Femoral Cutting block Guide SZ X- SM/SM, REF 216311001, non-sterile, Depuy International Leeds, England.
The product is used to make cuts in the femur to prepare the femur for total knee Terminated |
LXH | None listed |
| Feb 15, 2011 | Stryker Spine Mantis Tap Sleeve,Mfg by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401-1677. packaged in the following products:
Specialty Mantis Modular Tap Set - Catalog #IS2162MAN; Custom Tap Sleeve - Catalo Terminated |
LXH | None listed |
| Jan 19, 2011 | Stryker Howmedica Osteonics Corp. Scorpio Fixed Femoral A/P Sizing Guide; non-sterile instruments; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430; A subsidiary of Stryker Corporation
The A/P sizer is designed to set Terminated |
LXH | None listed |
| Jan 19, 2011 | Stryker Howmedica Osteonics Corp. Scorpio Adjustable Femoral A/P Sizing Guide Assembly;
non-sterile instruments; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430; A subsidiary of Stryker Corporation
The A/P sizer is d Terminated |
LXH | None listed |
| Jan 12, 2011 | Stryker Spine Disc Space Distractor
Label states - Specialty Disc Space Distractor, Mfg by: Stryker Spine 2 Pearl Court Allendale, NJ 07401-1677
Used to assist in spinal fusions. It is to be placed between the vert Terminated |
LXH | None listed |
| Jan 10, 2011 | Zimmer Inc. TiTLE 2 Polyaxial Spinal System, Counter Torque Assembly Tool, Part ET1132-01, Zimmer, Warsaw, IN.
The Zimmer Title 2 counter torque assembly tool is a reuseable, non- implantable surgical tool that Terminated |
LXH | None listed |
| Dec 28, 2010 | Biomet, Inc. Vanguard Knee Instruments offset reamer bushing - angled, REF 32-488519, Biomet Bridgend, UK.
This instrument is used to prepare the tibial cancellous bone for the tibial offset tray. Terminated |
LXH | None listed |
| Dec 27, 2010 | Stryker Howmedica Osteonics Corp. CuttingEdge Advantage Rasp Handle, Straight Rasp Handle, & Specialty Head Center Accolade Broach Handle; Stryker Howmedica Osteonics, Non-sterile Instruments; Howmedica Osteonics Corp., 325 Corporate Terminated |
LXH | None listed |
| Dec 13, 2010 | Zimmer Inc. NexGen Complete Knee Solution Rotating Hinge Knee tibial broach impactor, Catalog # 00-5881-080-00, Zimmer Inc., Warsaw, IN. Terminated |
LXH | None listed |
| Dec 13, 2010 | Zimmer Inc. NexGen Complete Knee Solution Stemmed tibial broach impactor, Catalog # 00-5977-011-00, Zimmer Inc., Warsaw, IN. Terminated |
LXH | K042271 K072619 +3 |
| Nov 26, 2010 | Stryker Howmedica Osteonics Corp. T2 Ankle Arthrodesis System Nail and Nut Adapter;
Stryker Trauma GmbH, Germany;
Distributed in USA by Howmedica, Osteonics Corp., 325 Corporate Drive, Mahwah, NJ Terminated |
LXH | None listed |
| Oct 15, 2010 | Zimmer Inc. Continuum Acetabular Systems Shell Inserter Adapter without Rotational Control, 00-8790-003-10, Zimmer Inc., Warsaw, IN.
Used to mate the inserter with the shell implant. Terminated |
LXH | K091508 |
| Oct 15, 2010 | Zimmer Inc. Continuum Acetabular Systems Shell Inserter Adapter with Rotational Control, 00-8790-003-00, Zimmer Inc., Warsaw, IN.
Used to mate the inserter with the shell implant. Terminated |
LXH | K091508 |
| Oct 13, 2010 | Stryker Howmedica Osteonics Corp. Scorpio/ NRG 4 i n1 Cutting Block
The Scorpio total knee system is indicated for primary Total knee Arthoplasty (TKA) procedures. The Scorpio Femoral Component is implanted on femur after making bone Terminated |
LXH | None listed |
| Oct 13, 2010 | Stryker Howmedica Osteonics Corp. Scorpio/ NRG 4 i n1 Cutting Block
The Scorpio total knee system is indicated for primary Total knee Arthoplasty (TKA) procedures. The Scorpio Femoral Component is implanted on femur after making bone Terminated |
LXH | None listed |
| Oct 13, 2010 | Stryker Howmedica Osteonics Corp. Scorpio/ NRG 4 i n1 Cutting Block
The Scorpio total knee system is indicated for primary Total knee Arthoplasty (TKA) procedures. The Scorpio Femoral Component is implanted on femur after making bone Terminated |
LXH | None listed |
| Oct 13, 2010 | Stryker Howmedica Osteonics Corp. Scorpio/ NRG 4 i n1 Cutting Block
The Scorpio total knee system is indicated for primary Total knee Arthoplasty (TKA) procedures. The Scorpio Femoral Component is implanted on femur after making bone Terminated |
LXH | None listed |
| Oct 13, 2010 | Stryker Howmedica Osteonics Corp. Scorpio/ NRG 4 i n1 Cutting Block
The Scorpio total knee system is indicated for primary Total knee Arthoplasty (TKA) procedures. The Scorpio Femoral Component is implanted on femur after making bone Terminated |
LXH | None listed |
| Oct 13, 2010 | Stryker Howmedica Osteonics Corp. Scorpio/ NRG 4 i n1 Cutting Block
The Scorpio total knee system is indicated for primary Total knee Arthoplasty (TKA) procedures. The Scorpio Femoral Component is implanted on femur after making bone Terminated |
LXH | None listed |
| Oct 13, 2010 | Stryker Howmedica Osteonics Corp. Scorpio/ NRG 4 in1 Cutting Block
The Scorpio total knee system is indicated for primary Total knee Arthoplasty (TKA) procedures. The Scorpio Femoral Component is implanted on femur after making bone c Terminated |
LXH | None listed |
| Oct 13, 2010 | Stryker Howmedica Osteonics Corp. Scorpio/ NRG 4in1 Cutting Block
The Scorpio total knee system is indicated for primary Total knee Arthoplasty (TKA) procedures. The Scorpio Femoral Component is implanted on femur after making bone cu Terminated |
LXH | None listed |
| Oct 13, 2010 | Stryker Howmedica Osteonics Corp. Scorpio/ NRG 4in1 Cutting Block
The Scorpio total knee system is indicated for primary Total knee Arthoplasty (TKA) procedures. The Scorpio Femoral Component is implanted on femur after making bone cu Terminated |
LXH | None listed |
| Oct 6, 2010 | Depuy Orthopaedics, Inc. Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143
Catalog Number: 2570-00-000
The Summit Broach Handle (instrumentation) is used with the Terminated |
LXH | None listed |
| Sep 30, 2010 | Encore Medical, Lp Glenoid Head Inserter (RSP Inserter/Impactor), Device Part #804-03-041, All Lots.
Product is a Shoulder Instrument used to place the Glenoid Head Trial onto the Baseplate Terminated |
LXH | None listed |
| Sep 28, 2010 | Biomet, Inc. 8 MM DISPOSABLE CORING TREPHINE STAGGERED TEETH WITH PROTECTION SLEEVE, REF 900788, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581.
Usage: Bone Coring Device used in ACL and PCL procedures. Terminated |
LXH | None listed |
| Sep 28, 2010 | Biomet, Inc. 10 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900740, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581.
Usage: Bone Coring Device used in ACL and PCL procedures. Terminated |
LXH | None listed |
| Sep 28, 2010 | Biomet, Inc. 9 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900739, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581.
Usage: Bone Coring Device used in ACL and PCL procedures. Terminated |
LXH | None listed |
| Sep 28, 2010 | Biomet, Inc. 8 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900738, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581.
Usage: Bone Coring Device used in ACL and PCL procedures. Terminated |
LXH | None listed |
| Sep 28, 2010 | Biomet, Inc. 7 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900737, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581.
Usage: Bone Coring Device used in ACL and PCL procedures. Terminated |
LXH | None listed |
| Sep 28, 2010 | Biomet, Inc. 10 MM DISPOSABLE CORING TREPHINE WITH PROTECTION SLEEVE, REF 900730, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581.
Usage: Bone Coring Device used in ACL and PCL procedures. Terminated |
LXH | None listed |
| Sep 28, 2010 | Biomet, Inc. 9 MM DISPOSABLE CORING TREPHINE WITH PROTECTION SLEEVE, REF 900729, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581.
Usage: Bone Coring Device used in ACL and PCL procedures. Terminated |
LXH | None listed |
| Sep 28, 2010 | Biomet, Inc. 8 MM DISPOSABLE CORING TREPHINE WITH PROTECTION SLEEVE, REF 900728, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581.
Usage: Bone Coring Device used in ACL and PCL procedures. Terminated |
LXH | None listed |
| Sep 28, 2010 | Biomet, Inc. 7 MM DISPOSABLE CORING TREPHINE WITH PROTECTION SLEEVE, REF 900727, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581.
Usage: Bone Coring Device used in ACL and PCL procedures. Terminated |
LXH | None listed |
| Sep 25, 2010 | Biomet, Inc. Modular Microplasty Cup impactor 1/4" - 28 thread insert , REF 31-400605 Terminated |
LXH | None listed |
| Sep 25, 2010 | Biomet, Inc. Modular Microplasty Cup inserter 3/8" thread , REF 31-400600 Terminated |
LXH | None listed |
| Aug 26, 2010 | Zimmer Inc. Zimmer ITST" INTERTROCHANTERIC/SUBTROCHANTERIC FIXATION LOCKING BOLT EXTRACTOR - NONSTERILE
Zimmer, Warsaw, IN 46580, U.S.A. The ITST Intertrochanteric/Subtrochanteric Fixation Locking Bolt Extractor Terminated |
LXH | 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 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 |
| Aug 2, 2010 | Encore Medical, Lp MIKA Speedblock, Size 8-12.
The MIKA Speedblock is placed on the distal femur as a guide for making the anterior, posterior and both chamfer cuts. Terminated |
LXH | None listed |
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