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) |
|---|---|---|---|
| Oct 8, 2014 | DePuy Orthopaedics, Inc. RECLAIM Distal Reamer Extension
Non Sterile
REF 2975-00-500
Intended as an attachment device to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal. Terminated |
LXH | None listed |
| Sep 11, 2014 | Stryker Spine Specialty Aria Inserter, REF IS3021ARI, Non-Sterile,
This instrument is part of the Aria product brand. It is used for Implant insertion into the disc space. The Aria Inserter PEEK Spacer System of Terminated |
LXH | None listed |
| Sep 11, 2014 | Stryker Spine Stryker Aria Implant Inserter, REF 48758500,
This instrument is part of the Aria product brand. It is used for Implant insertion into the disc space. The Aria Inserter PEEK Spacer System offers imp Terminated |
LXH | None listed |
| Aug 26, 2014 | Zimmer, Inc. Knee Instrument Fixation Screws:
48MM HEADED SCREW
48MM HEADLESS SCREW
MIS HEADED SCREW, 48MM
MIS HEADLESS SCREW, 48MM Terminated |
LXH | None listed |
| Aug 22, 2014 | Zimmer, Inc. Zimmer PERSONA Distal Valgus Alignment Guide, Nonsterile. orthopedic surgical instrument.
The device sets the proper Varus/Valgus alignment of a patient's knee prior to the initial femoral resectio Terminated |
LXH | None listed |
| Aug 14, 2014 | Zimmer, Inc. 23.5 Deg Rasp Handle Assy- RIGHT
Nonsterile Terminated |
LXH | None listed |
| Aug 14, 2014 | Zimmer, Inc. 23.5 Deg Rasp Handle Assy- LEFT
Nonsterile Terminated |
LXH | None listed |
| Aug 14, 2014 | Zimmer, Inc. VER2 HANDLE, PIN REWORK, RT
Nonsterile Terminated |
LXH | None listed |
| Aug 14, 2014 | Zimmer, Inc. VER2 HANDLE, PIN REWORK, LT
Nonsterile Terminated |
LXH | None listed |
| Aug 14, 2014 | Zimmer, Inc. Double Offset Rasp Handle, Right Hand
A/S Rasp Handle (Right) Terminated |
LXH | None listed |
| Aug 14, 2014 | Zimmer, Inc. Double Offset Rasp Handle, Left Hand
A/S Rasp Handle (Left) Terminated |
LXH | None listed |
| Aug 14, 2014 | Zimmer, Inc. VER2 D8L OFFSET RASP HANDLE, RT
Nonsterile Terminated |
LXH | None listed |
| Aug 14, 2014 | Zimmer, Inc. VER2 DBL OFFSET RASP HANDLE, LT
Nonsterile Terminated |
LXH | None listed |
| Aug 14, 2014 | Zimmer, Inc. Vl DBL OFFST WI LRG STPL, RT
Nonsterile Terminated |
LXH | None listed |
| Aug 14, 2014 | Zimmer, Inc. Double Offset Rasp Handle, Right Hand
Nonsterile Terminated |
LXH | None listed |
| Aug 14, 2014 | Zimmer, Inc. Double Offset Rasp Handle, Left Hand
Nonsterile Terminated |
LXH | None listed |
| Aug 14, 2014 | Zimmer, Inc. Double Offset Rasp Handle, Right Hand
Nonsterile Terminated |
LXH | None listed |
| Aug 14, 2014 | Zimmer, Inc. VI DBL OFFST W/ LRG STPL, LT
Nonsterile Terminated |
LXH | None listed |
| Aug 14, 2014 | Zimmer, Inc. Double Offset Rasp Handle, Left Hand
Nonsterile Terminated |
LXH | None listed |
| Aug 14, 2014 | Zimmer, Inc. Double Offset Rasp Handle, Left Hand
Nonsterile Terminated |
LXH | None listed |
| Aug 14, 2014 | Zimmer, Inc. Double Offset Rasp Handle, Left Hand
Nonsterile Terminated |
LXH | None listed |
| Jul 21, 2014 | Synthes, Inc. Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). Orthopedic surgical instrument. Terminated |
LXH | None listed |
| Jul 2, 2014 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Triathlon Tritanium Patella Inserter, . NON-STERILE
Product Usage:
The Triathlon Tritanium Patella Inserter is part of the Tritanium Knee System Instrument Set. It is used to imp Terminated |
LXH | None listed |
| Jun 16, 2014 | Biomet, Inc. EZPass Nylon Monofilament Single Pack, Part number 110007379, Orthopedic Manual Surgical Instrument Sterile, single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in pa Terminated |
LXH | None listed |
| Jun 16, 2014 | Biomet, Inc. EZPass Suture Retriever, Nitinol, Single Pack, Part number 10007380. Orthopedic Manual Surgical Instrument, Sterile, single use arthroscopic instrument utilized in conjunction with a nitinol wire to Terminated |
LXH | None listed |
| Jun 4, 2014 | Microport Orthopedics INC. PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Orthopaedic surgical instrument. Terminated |
LXH | None listed |
| Mar 20, 2014 | Biomet, Inc. Part 475630, Intramedullary Bone Saw, Cam Assembly
Size 14 mm,
The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instrument that is used to correct leg length, or rotational di Terminated |
LXH | None listed |
| Mar 20, 2014 | Biomet, Inc. Part 475625, Intramedullary Bone Saw, Cam Assembly
Size 13 mm,
The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instrument that is used to correct leg length, or rotational dis Terminated |
LXH | None listed |
| Mar 20, 2014 | Biomet, Inc. Part 475620 Intramedullary Bone Saw CAM Assembly
Size 12mm,
A unique and exclusive clinical instrument used to correct leg length, or rotational discrepancies in the femur. Terminated |
LXH | None listed |
| Feb 25, 2014 | Stryker Spine Specialty Straight Static Inserter Assembly
Product Usage: This instrument is a part of the Navigator product brand . It is used for implant insertion in to the disc space. The AVS navigator Peek Terminated |
LXH | None listed |
| Feb 20, 2014 | Synthes, Inc. Synthes Driving Cap/Threaded
Both parts are intended for use in the Tibia system, LFN and RAFN systems. Their function is to insert a nail. The Synthes Driving Cap/Threaded is threaded into the inser Terminated |
LXH | None listed |
| Feb 16, 2014 | Synthes, Inc. Synthes 3.2 mm Guide Wire 400mm.
Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral. Terminated |
LXH | None listed |
| Feb 10, 2014 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Navigation Compatible Accolade Broach Handle
1 single unit to a package
Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA
Stryker France ZAC Satolas Green Pusigna Terminated |
LXH | None listed |
| Jan 9, 2014 | ArthroCare Medical Corporation Arthrocare SPORTS MEDICINE, Knot Pusher, REF 25-3011, LOT #1049402, CON 1, 2013-10, NON-STERILE, Rx only Terminated |
LXH | None listed |
| Nov 27, 2013 | DePuy Orthopaedics, Inc. SIGMA LCS HIGH PERFORMANCE"
MBT PUNCH NONCEMENTED
Size 2-3
HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used Terminated |
LXH | K032151 K033272 |
| Nov 27, 2013 | DePuy Orthopaedics, Inc. SIGMA LCS HIGH PERFORMANCE"
MBT PUNCH NONCEMENTED
Size 1-1.5
HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray us Terminated |
LXH | K032151 K033272 |
| Nov 27, 2013 | Synthes USA HQ, Inc. Synthes Implant Holder for Synfix (TM)-LR
the Synthes Implant Holder for Synfix (TM)-LR is a non-powered hand-held device intended for medical purposes to manipulate tissue, or for use with other dev Terminated |
LXH | None listed |
| Nov 26, 2013 | Synthes USA HQ, Inc. Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor Rack, T-PAL Spacer Remover, Implant Inserter)
Synthes Material Mix: Adjustable Cervical Distractor-Right is used to distr Terminated |
LXH | None listed |
| Nov 25, 2013 | Synthes USA HQ, Inc. Synthes Tensioning Device
The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthrosis or non-unions of long bones, limb lengthening by epiphy Terminated |
LXH | None listed |
| Nov 22, 2013 | Synthes USA HQ, Inc. Synthes Matrix Threaded Persuader
Deformity is a comprehensive thoracolumbar pedical screw system designed to provide flexibility biomechanical performance and a solution to complex posterior patholo Terminated |
LXH | None listed |
| Nov 21, 2013 | Stryker Spine Stryker
1) XIA Torque Wrench
2) XIA 3 Torque Wrench
3) XIA Elegance Short Torque Wrench
Manufactured by: Stryker Spine SAS Z.I. Marticot -33610 -CESTAS -FRANCE +33 (0) 5.57.97.06.30
http://www.stryk Terminated |
LXH | None listed |
| Nov 19, 2013 | Aesculap, Inc. Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US) Terminated |
LXH | None listed |
| Nov 14, 2013 | SpineFrontier, Inc. S-LIFT Extension Shims
Extension shims are manufactured from grade 5 titanium and are curved, rectangular slabs which have four protrusions used for ratcheting. They come in straight and pointed varie Terminated |
LXH | K092815 |
| Nov 13, 2013 | Synthes USA HQ, Inc. Synthes 8.5 MM Medullary Reamer
Product Usage:
An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other dev Terminated |
LXH | None listed |
| Sep 26, 2013 | Synthes USA HQ, Inc. Synthes Oracle Spacer System Slap Hammer, Part Number 03.809.690, Lot Number 3723847
The Oracle Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous l Terminated |
LXH | None listed |
| Sep 17, 2013 | Ebi, Llc Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cervical spinal fixation device.
1)Screw Tower - REF 14-501660
2) Rod Reduce - REF 14-501661
3) Counter Terminated |
LXH | None listed |
| Aug 12, 2013 | Zimmer, Inc. REF 00-4309-071-40 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere Helmet, 40 mm Diameter Nonsterile, Qty -1
Instrumentation used in shoulder replacement surgery. The glenospher Terminated |
LXH | None listed |
| Aug 12, 2013 | Zimmer, Inc. REF 00-4309-071-36 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere Helmet, 36 mm Diameter Nonsterile, Qty -1
Instrumentation used in shoulder replacement surgery. The glenospher Terminated |
LXH | None listed |
| Jul 29, 2013 | Synthes USA HQ, Inc. Synthes Synapse SD Drill Guide, Part Number SD389.477, Lot Number 6913900
Indicated for Hooks, Plate/Rods, Rods and Screws when intended to promote fusion of the cervical spine fusion of the cervical Terminated |
LXH | None listed |
| Jul 5, 2013 | SpineFrontier, Inc. S-LIFT Inserter Outer Sleeve
Product Usage:
The Inserter Sleeve is an optional instrument to add further compression of the Inserter into the Implant during implantation of S-LIF Intervertebral Body Terminated |
LXH | K092815 |
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