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 2, 2010 | Stryker Howmedica Osteonics Corp. Howmedica Osteonics Corp.,
Stryker Orthopaedics Passport A.R. Knee Instrumentation Anterior Skim Guide; Catalog Number 7650-5003. Terminated |
LXH | None listed |
| Aug 2, 2010 | Stryker Howmedica Osteonics Corp. X-Celerate Instrumentation Punch Thru Tibial Base Plate, Catalog numbers: 3750-0003. 3750-0004, 3750-0005, 3740-0006, 3750-0007, 3750-0009, 3750-0011, 3750-0013;
Stryker Howmedica Osteonics Corp Scor Terminated |
LXH | None listed |
| Aug 2, 2010 | Stryker Howmedica Osteonics Corp. Howmedica Osteonics Corp,
Stryker Orthopaedics Passport A.R. Knee Instrumentation Distal Guide Stand; Catalog number 7650-5005. Terminated |
LXH | None listed |
| Jun 24, 2010 | Smith & Nephew Inc GENESIS II TIBIAL DRILL GUIDE, REF 71440238, SIZE 5, QTY: (1), NON-STERILE, Smith & Nephew, Inc., Memphis, TN 38116, USA
Drill guide used as manual surgical instrument during knee replacement surge Terminated |
LXH | None listed |
| Jun 16, 2010 | Synthes USA (HQ), Inc. Synthes Medullary Tubes Terminated |
LXH | None listed |
| Jun 7, 2010 | Wright Medical Technology Inc RAYHACK DRILL GUIDE ANGLED, REF 4010-0206, 1 EACH, Rx ONLY, NON-STERILE, Wright Medical EMEA Krijgsman 11, 1186 Amstelveen, The Netherlands, Wright Medical Technology, 4677 Airline Road, Arlington, TN Terminated |
LXH | None listed |
| May 10, 2010 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics, Duracon 4:1 Ceramic Cutting Block XXL; XCelerate cutting block for distal femur in orthopaedic surgery,
Non-Sterile. Terminated |
LXH | None listed |
| May 10, 2010 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics, Duracon 4:1 Ceramic Cutting Block XL;
XCelerate cutting block for distal femur in orthopaedic surgery, Non-Sterile. Terminated |
LXH | None listed |
| May 10, 2010 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics, Duracon 4:1 Ceramic Cutting Block LG;
XCelerate cutting block for distal femur in orthopaedic surgery, Non-Sterile. Terminated |
LXH | None listed |
| May 10, 2010 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics, Duracon 4:1 Ceramic Cutting Block ML;
XCelerate cutting block for distal femur in orthopaedic surgery, Non-Sterile. Terminated |
LXH | None listed |
| May 10, 2010 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics, Duracon 4:1 Ceramic Cutting Block MED;
XCelerate cutting block for distal femur in orthopaedic surgery, Non-Sterile. Terminated |
LXH | None listed |
| May 10, 2010 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics, Duracon 4:1 Ceramic Cutting Block SM;
XCelerate cutting block for distal femur in orthopaedic surgery, Non-Sterile. Terminated |
LXH | None listed |
| May 10, 2010 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics, Duracon 4:1 Ceramic Cutting Block XS;
XCelerate cutting block for distal femur in orthopaedic surgery, Non-Sterile. Terminated |
LXH | None listed |
| May 10, 2010 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics, Scorpio Ceramic 4:1 Guide Size 13;
XCelerate cutting block for distal femur in orthopaedic surgery, Non Sterile Terminated |
LXH | None listed |
| May 10, 2010 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics, Scorpio Ceramic 4:1 Guide Size 11;
XCelerate cutting block for distal femur in orthopaedic surgery, Non Sterile Terminated |
LXH | None listed |
| May 10, 2010 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics, Scorpio Ceramic 4:1 Guide Size 9;
XCelerate cutting block for distal femur in orthopaedic surgery, Non Sterile Terminated |
LXH | None listed |
| May 10, 2010 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics, Scorpio Ceramic 4:1 Guide Size 8;
XCelerate cutting block for distal femur in orthopaedic surgery, Non Sterile Terminated |
LXH | None listed |
| May 10, 2010 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics, Scorpio Ceramic 4:1 Guide Size 7;
XCelerate cutting block for distal femur in orthopaedic surgery, Non Sterile Terminated |
LXH | None listed |
| May 10, 2010 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics, Scorpio Ceramic 4:1 Guide Size 6;
XCelerate cutting block for distal femur in orthopaedic surgery, Non Sterile Terminated |
LXH | None listed |
| May 10, 2010 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics, Scorpio Ceramic 4:1 Guide Size 5;
XCelerate cutting block for distal femur in orthopaedic surgery, Non Sterile Terminated |
LXH | None listed |
| May 10, 2010 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics, Scorpio Ceramic 4:1 Guide Size 4;
XCelerate cutting block for distal femur in orthopaedic surgery, Non Sterile Terminated |
LXH | None listed |
| May 10, 2010 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics, Scorpio Ceramic 4:1 Guide Size 3;
XCelerate cutting block for distal femur in orthopaedic surgery, Non Sterile Terminated |
LXH | None listed |
| Apr 15, 2010 | Orthohelix Surgical Designs Inc Quick Connect Adapter Model #CSS-QA-Adapter MaxTorque(R) Maxtorque Quick Connect Lot #s: 1014001 & 1101011, QTY 1 NON STERILE MAT:17-4PH
The intended use: Used to stabilize and aid in the fixation Terminated |
LXH | None listed |
| Mar 23, 2010 | Stryker Craniomaxillofacial Division Tessier Osseous Microtome TOM(R) Bone Mill, 01-15402, Stryker Portage, MI.
The TOM bone mill is designed to grind any type of cortical or cancellous bone. Terminated |
LXH | None listed |
| Feb 16, 2010 | Stryker Spine Stryker Xia Precision System; Jam Shidi 11 Gauge 5 inch; Sterile; Manufactured for: Stryker Spine SAS, Cestas, France; Distributed in the US by Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, N Terminated |
LXH | None listed |
| Feb 16, 2010 | Stryker Spine Stryker Xia Precision System; Jam Shidi 10 Gauge 5 inch; Sterile; Manufactured for: Stryker Spine SAS, Cestas, France; Distributed in the US by Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, N Terminated |
LXH | None listed |
| Feb 16, 2010 | Stryker Spine Stryker Xia Precision System; Jam Shidi 10 Gauge 9 inch; Sterile; Manufactured for: Stryker Spine SAS, Cestas, France; Distributed in the US by Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, N Terminated |
LXH | None listed |
| Jan 15, 2010 | Biomet, Inc. Biomet Vanguard Lock-On Femoral Impactor, Biomet Orthopedics. Warsaw. IN; REF 32-486206.
Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery; Terminated |
LXH | None listed |
| Jan 12, 2010 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek Extended Length Trocar, Size : L=50MM, Item No.: 7578014, Mat'l: Stainless Steel, non-sterile, Rx only, Trocars used with the CD HORIZON LEGACY" Percutaneous Peek Spinal Sys Terminated |
LXH | None listed |
| Jan 12, 2010 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek Extended Length Trocar, Item No.: 7578013, Mat'l: Stainless Steel, non-sterile, Rx only, Trocars used with the CD HORIZON LEGACY" Percutaneous Peek Spinal System Terminated |
LXH | None listed |
| Nov 10, 2009 | Biomet Microfixation, Inc. Byrd Screw, 2.0X6MM SD, Model Number: 01-0264
Product labeling reads in part as follows:
REF: 01-0264, QTY,UOM 00001, BYRD SCREW, 2 OX6MM SELF-DRILLING, 12CM, (4-3/4) (L), STAINLESS STEEL, LOT 99999 Terminated |
LXH | None listed |
| Aug 26, 2009 | Stryker Howmedica Osteonics Corp. Triathlon MIS 4:1 Cutting Blocks - Size 1-8;
Catalog Numbers: 6541-5-701, 6541-5-702, 6541-5-703, 6541-5-704, 6541-5-705, 6541-5-706, 6541-5-707, & 6541-5-708;
Triathlon MIS Instruments;
Non Sterile:
Terminated |
LXH | None listed |
| Aug 26, 2009 | Stryker Howmedica Osteonics Corp. Triathlon AR 4:1 Cutting Blocks - Size 1-8;
Catalog Numbers: 6541-0-701, 6541-0-702, 6541-0-703, 6541-0-704, 6541-0-705, 6541-0-706, 6541-0-707, & 6541-0-708;
Triathlon MIS Instruments;
Non Sterile
St Terminated |
LXH | None listed |
| Aug 4, 2009 | Smith & Nephew Inc IMHS CP, 3.2mm, Tip Threaded Guide Pin, REF71687000, for use with IntraMedullary Hip Screw in orthopedic surgery. Terminated |
LXH | None listed |
| Jun 1, 2009 | Biomet, Inc. Biomet Dual Offset Broach Handle, Clamping Style, Right, REF 31-555404. For use in primary hip arthroplasty. Terminated |
LXH | None listed |
| Jun 1, 2009 | Biomet, Inc. Biomet Dual Offset Broach Handle, Clamping Style, Left, REF 31-555403. For use in primary hip arthroplasty. Terminated |
LXH | None listed |
| Apr 28, 2009 | Wright Medical Technology Inc Screwdriver for 3.5mm Screws, DARCO system, instrument for use in orthopaedic implant surgery. REF: DC4261, Non-sterile, Rx only, 1 each, Wright Medical Technology, Inc., 5677 Airline, Road, Arlingto Terminated |
LXH | None listed |
| Feb 27, 2009 | Zimmer Inc. Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 30 degrees, Zimmer, Warsaw, IN; REF 00-7806-035-02.
The offset rasp handle is a surgical instrument used with various sizes o Terminated |
LXH | None listed |
| Feb 27, 2009 | Zimmer Inc. Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Left, 30 degrees, Zimmer, Warsaw, IN; REF 00-7806-035-01.
The offset rasp handle is a surgical instrument used with various sizes of Terminated |
LXH | None listed |
| Jan 23, 2009 | Integra LifeSciences Corp. Integra Ruggles Surgical Instrument ACF Distraction Screws
Sterile, Rx only
Catalog number R6357A (12 mm), Catalog number R6397A (16 mm),
Integra LifeSciences Corp., 311 Enterprise Drive, Plainsboro, Terminated |
LXH | None listed |
| Jan 7, 2009 | Biomet, Inc. Compress Short Anchor Plug Holder, 13mm, Biomet Orthopedics, Inc., Warsaw, IN; REF CP461038.
Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surge Terminated |
LXH | None listed |
| Jan 7, 2009 | Biomet, Inc. Compress Short Instruments Anchor Plug Holder, 12mm, stainless steel, non-sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF CP460193.
Non-powered, hand-held device intended for medical purposes for Terminated |
LXH | None listed |
| Jan 7, 2009 | Biomet, Inc. Compress/Finn Instrument Set Compress Anchor Plug Assembly, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF RD425032.
Non-powered, hand-held device intended for medical purposes for use wi Terminated |
LXH | None listed |
| Jan 7, 2009 | Biomet, Inc. Compress Instrument 13mm Anchor Plug Holder, stainless steel/TiAIN, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-481091.
Non-powered, hand-held device intended for medical purposes for use with other Terminated |
LXH | None listed |
| Jan 7, 2009 | Biomet, Inc. Compress Instrument Anchor Plug Holder, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-481006.
Non-powered, hand-held device intended for medical purposes for use with other devices in Terminated |
LXH | None listed |
| Oct 28, 2008 | Stryker Howmedica Osteonics Corp. Stryker Osteosynthesis Reduction Spoon;
1 single unit to a package; non-sterile;
Stryker Trauma GmbH, 2432 Schonkirchen, Germany.
Distributed in the US by Howmedica Osteonics Corp., 325 Corporate Driv Terminated |
LXH | None listed |
| Oct 24, 2008 | Biomet, Inc. Biomet brand Modular Microplasty Cup Inserter, 3/8" thread, Biomet Orthopedics, Inc., Warsaw, IN; Model 31-400600. Non-powered, hand-held instrument intended for use as an impactor during orthopedic Terminated |
LXH | None listed |
| Sep 20, 2008 | Stryker Howmedica Osteonics Corp. X-Celerate Universal Block Pegless Size #3,
Non Sterile; Terminated |
LXH | None listed |
| Sep 20, 2008 | Stryker Howmedica Osteonics Corp. Universal Notch Preparation Guide, Size #3;
Non Sterile;
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430;
authorized representative in Europe:
Stryker France ZAC Satolas Green Pusignan; Terminated |
LXH | None listed |
| Sep 18, 2008 | Kyphon Inc KyphX Osteo Introducer System with blunt tip introducer stylet (as contained in the KyphoPak Tray, First Fracture, 15/3 Xpander), catalog number KPT1502, manufactured by Medtronic Spine LLC. Device i Terminated |
LXH | None listed |
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