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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)
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Top companies in LXH

DateFirm and productCodeLinked 510(k)
Oct 8, 2014DePuy 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
LXHNone listed
Sep 11, 2014Stryker 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
LXHNone listed
Sep 11, 2014Stryker 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
LXHNone listed
Aug 26, 2014Zimmer, Inc.
Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW MIS HEADED SCREW, 48MM MIS HEADLESS SCREW, 48MM
Terminated
LXHNone listed
Aug 22, 2014Zimmer, 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
LXHNone listed
Aug 14, 2014Zimmer, Inc.
23.5 Deg Rasp Handle Assy- RIGHT Nonsterile
Terminated
LXHNone listed
Aug 14, 2014Zimmer, Inc.
23.5 Deg Rasp Handle Assy- LEFT Nonsterile
Terminated
LXHNone listed
Aug 14, 2014Zimmer, Inc.
VER2 HANDLE, PIN REWORK, RT Nonsterile
Terminated
LXHNone listed
Aug 14, 2014Zimmer, Inc.
VER2 HANDLE, PIN REWORK, LT Nonsterile
Terminated
LXHNone listed
Aug 14, 2014Zimmer, Inc.
Double Offset Rasp Handle, Right Hand A/S Rasp Handle (Right)
Terminated
LXHNone listed
Aug 14, 2014Zimmer, Inc.
Double Offset Rasp Handle, Left Hand A/S Rasp Handle (Left)
Terminated
LXHNone listed
Aug 14, 2014Zimmer, Inc.
VER2 D8L OFFSET RASP HANDLE, RT Nonsterile
Terminated
LXHNone listed
Aug 14, 2014Zimmer, Inc.
VER2 DBL OFFSET RASP HANDLE, LT Nonsterile
Terminated
LXHNone listed
Aug 14, 2014Zimmer, Inc.
Vl DBL OFFST WI LRG STPL, RT Nonsterile
Terminated
LXHNone listed
Aug 14, 2014Zimmer, Inc.
Double Offset Rasp Handle, Right Hand Nonsterile
Terminated
LXHNone listed
Aug 14, 2014Zimmer, Inc.
Double Offset Rasp Handle, Left Hand Nonsterile
Terminated
LXHNone listed
Aug 14, 2014Zimmer, Inc.
Double Offset Rasp Handle, Right Hand Nonsterile
Terminated
LXHNone listed
Aug 14, 2014Zimmer, Inc.
VI DBL OFFST W/ LRG STPL, LT Nonsterile
Terminated
LXHNone listed
Aug 14, 2014Zimmer, Inc.
Double Offset Rasp Handle, Left Hand Nonsterile
Terminated
LXHNone listed
Aug 14, 2014Zimmer, Inc.
Double Offset Rasp Handle, Left Hand Nonsterile
Terminated
LXHNone listed
Aug 14, 2014Zimmer, Inc.
Double Offset Rasp Handle, Left Hand Nonsterile
Terminated
LXHNone listed
Jul 21, 2014Synthes, Inc.
Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). Orthopedic surgical instrument.
Terminated
LXHNone listed
Jul 2, 2014Stryker 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
LXHNone listed
Jun 16, 2014Biomet, 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
LXHNone listed
Jun 16, 2014Biomet, 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
LXHNone listed
Jun 4, 2014Microport Orthopedics INC.
PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Orthopaedic surgical instrument.
Terminated
LXHNone listed
Mar 20, 2014Biomet, 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
LXHNone listed
Mar 20, 2014Biomet, 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
LXHNone listed
Mar 20, 2014Biomet, 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
LXHNone listed
Feb 25, 2014Stryker 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
LXHNone listed
Feb 20, 2014Synthes, 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
LXHNone listed
Feb 16, 2014Synthes, Inc.
Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral.
Terminated
LXHNone listed
Feb 10, 2014Stryker 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
LXHNone listed
Jan 9, 2014ArthroCare Medical Corporation
Arthrocare SPORTS MEDICINE, Knot Pusher, REF 25-3011, LOT #1049402, CON 1, 2013-10, NON-STERILE, Rx only
Terminated
LXHNone listed
Nov 27, 2013DePuy 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
LXHK032151
K033272
Nov 27, 2013DePuy 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
LXHK032151
K033272
Nov 27, 2013Synthes 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
LXHNone listed
Nov 26, 2013Synthes 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
LXHNone listed
Nov 25, 2013Synthes 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
LXHNone listed
Nov 22, 2013Synthes 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
LXHNone listed
Nov 21, 2013Stryker 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
LXHNone listed
Nov 19, 2013Aesculap, Inc.
Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)
Terminated
LXHNone listed
Nov 14, 2013SpineFrontier, 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
LXHK092815
Nov 13, 2013Synthes 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
LXHNone listed
Sep 26, 2013Synthes 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
LXHNone listed
Sep 17, 2013Ebi, 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
LXHNone listed
Aug 12, 2013Zimmer, 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
LXHNone listed
Aug 12, 2013Zimmer, 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
LXHNone listed
Jul 29, 2013Synthes 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
LXHNone listed
Jul 5, 2013SpineFrontier, 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
LXHK092815

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