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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)
Jan 6, 2017DePuy Orthopaedics, Inc.
DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures
Terminated
LXHNone listed
Dec 22, 2016Flower Orthopedics Corporation
Cannulated Drill bit 2.0mm and 2.6 mm; Used in conjunction with the Flower Bone Screw Set.
Terminated
LXHNone listed
Dec 14, 2016MEDLINE INDUSTRIES INC
12 mm Distraction Pin, Blunt Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with
Terminated
LXHNone listed
Dec 14, 2016MEDLINE INDUSTRIES INC
14 mm Distraction Pin, Exagg Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with
Terminated
LXHNone listed
Dec 14, 2016MEDLINE INDUSTRIES INC
10 mm Distraction Pin, Aggressive Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use
Terminated
LXHNone listed
Dec 14, 2016MEDLINE INDUSTRIES INC
16 mm [or 18 mm] Distraction Pin, Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use
Terminated
LXHNone listed
Dec 14, 2016MEDLINE INDUSTRIES INC
16 mm Distraction Pin, Titanium, Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use
Terminated
LXHNone listed
Dec 2, 2016Stryker Howmedica Osteonics Corp.
Reunion TSA Peg Alignment Sound Catalog #5901-1038 The Peg Alignment Sound (PIN 5901-1038, Revision A) is an instrument used in the ReUnion TSA shoulder system for confirming seating height and peg a
Terminated
LXHNone listed
Nov 22, 2016Amendia, Inc
Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone
Terminated
LXHNone listed
Nov 19, 2016Synthes (USA) Products LLC
Extraction Hook - Sterile for TI Cannulated Nails
Terminated
LXHNone listed
Nov 15, 2016Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
CARPAL TUNNEL PACK, Surgical Instrument Tray, REF/Catalog No. 3366, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # D190549.
Terminated
LXHNone listed
Nov 4, 2016Thayer Intellectual Property, Inc.
MANOS EX (CAT#TY-12-101) Product Usage: Carpal Tunnel Release: as a tool for tissue release of the transverse carpal ligament in patients with Carpal Tunnel Syndrome who fail conservative therapy. Pl
Terminated
LXHNone listed
Oct 19, 2016Greatbatch Medical
Offset Reamer Handle, T5766 Product Usage: The reamer handles are re-usable surgical instruments used in arthroplasty surgery of the hip joints, where either total joint replacement or resurfacing su
Terminated
LXHNone listed
Oct 14, 2016Zimmer Biomet, Inc.
Phoenix Recon Targeting Arm Guide, Surgical, Instrument for the sleeve and Orthopedic Manual Surgical Instruments for the Arm Product Usage: The Phoenix Femoral Nail System is to be implanted into th
Terminated
LXHNone listed
Oct 5, 2016LDR Spine USA, Inc.
ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device.
Terminated
LXHK082262
K090507 +2
Sep 23, 2016Cardinal Health 200, LLC
V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.
Terminated
LXHNone listed
Aug 31, 2016Limacorporate S.p.A
SMR allen wrench 5 mm, product code 9013.50.210
Terminated
LXHNone listed
Aug 2, 2016Zimmer Gmbh
V-TEK TWIST D 40X90MM 30MM Cann 12MM Rnd; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.
Terminated
LXHNone listed
Aug 2, 2016Zimmer Gmbh
V-TEK TWIST D 3.5X90MM 30MM Can 12MM Rnd; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.
Terminated
LXHNone listed
Aug 2, 2016Zimmer Gmbh
TWIST D 28X150MM CBS 45 Cann 14 MM AO; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.
Terminated
LXHNone listed
Aug 2, 2016Zimmer Gmbh
TWIST DR 25X95MM Cann 12MM Thd 30MM AO; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.
Terminated
LXHNone listed
May 26, 2016Biomet, Inc.
Various trauma and sports medicine instruments and implants. Orthopedic manual surgical instrument.
Terminated
LXHNone listed
Feb 25, 2016Biomet, Inc.
HipLOC CHS Plate/Lag Screw Introducer
Terminated
LXHNone listed
Jan 5, 2016Biomet U.K., Ltd.
Oxford Unicompartmental Knee Phase 3 Shim Size 1 Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Terminated
LXHNone listed
Jan 5, 2016Biomet U.K., Ltd.
Oxford Unicompartmental Knee Phase 3 Shim Size 2 Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Terminated
LXHNone listed
Jan 5, 2016Biomet U.K., Ltd.
Oxford Unicompartmental Knee Phase 3 Shim Size 3 Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Terminated
LXHNone listed
Jan 5, 2016Biomet U.K., Ltd.
Oxford Partial Knee System Femoral Slap Hammer Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Terminated
LXHNone listed
Jan 5, 2016Biomet U.K., Ltd.
Oxford Knee System Tibial Resector Body Tube & Guides Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Terminated
LXHNone listed
Dec 18, 2015Stryker Spine
Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manufactured by : Stryker Spine SAS France Used to facilitate insertion of the Aero-AL cage into the disc space.
Terminated
LXHNone listed
Dec 10, 2015Zimmer, Inc.
Persona EM Distal Rod, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-002-00, part of the Persona Tibial Resection System.
Terminated
LXHNone listed
Dec 10, 2015Zimmer, Inc.
Persona EM Proximal Tube, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-001-00, part of the Persona Tibial Resection System.
Terminated
LXHNone listed
Nov 5, 2015Stryker Spine
Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number 48590100. Manual Surgical Instrument.
Terminated
LXHNone listed
Oct 7, 2015DePuy Orthopaedics, Inc.
Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument (PN 96-6120) The SP2 IM Rod 400mm Instrument (PN 96-6120) is used in both primary and revision P.F.C. SIGMA knee procedures to align the femor
Terminated
LXHNone listed
Oct 5, 2015Synthes (USA) Products LLC
Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates and Periarticular Aiming Arm for 4.5mm LCP Proximal Tibia Plates
Terminated
LXHNone listed
Sep 3, 2015Synthes (USA) Products LLC
Inserter for Titanium Elastic Nails (TEN), orthopedic device
Terminated
LXHNone listed
May 29, 2015Zimmer, Inc.
PRI Femoral Impactor Block for knee prosthesis surgery. Orthopedic Manual Surgical Instrument
Terminated
LXHNone listed
Apr 27, 2015Zimmer Gmbh
Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder.
Terminated
LXHNone listed
Apr 21, 2015Captiva Spine, Inc
Captiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers).
Terminated
LXHNone listed
Apr 7, 2015Bacterin International, Inc.
Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is used to insert OsteoSponge SC grafts to fill bone defects in the subchondral region of articulating joints. The Instrument Ki
Terminated
LXHNone listed
Mar 31, 2015DePuy Orthopaedics, Inc.
RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instrument for hip implantation.
Terminated
LXHNone listed
Mar 10, 2015Synthes, Inc.
Synthes Inserter for Titanium Elastic Nails; The Inserter for Titanium Elastic Nails (TEN) is intended for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is p
Terminated
LXHNone listed
Jan 14, 2015SpineFrontier, Inc.
lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164
Terminated
LXHNone listed
Jan 12, 2015DePuy Orthopaedics, Inc.
The ATTUNE INTUITION Impaction Handle is a re-useable instrument utilized in knee replacement procedures. The instrument interfaces with several related ATTUNE instruments: keel punch, tibial tower, e
Terminated
LXHNone listed
Jan 5, 2015DePuy Orthopaedics, Inc.
I.M. Hole Locator Instrument. Orthopedic manual surgical instrument. The IM Hole locator guides the IM drill during IM Hole preparation. The instrument is positioned between the condyles and ali
Terminated
LXHNone listed
Jan 5, 2015DePuy Orthopaedics, Inc.
Femoral Impactor ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times wi
Terminated
LXHNone listed
Jan 5, 2015DePuy Orthopaedics, Inc.
Rotating Tibial Platform ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various
Terminated
LXHNone listed
Jan 5, 2015DePuy Orthopaedics, Inc.
Fixed Tibial bearing ATTUNE INTUITION Impactor The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times
Terminated
LXHNone listed
Dec 16, 2014Stryker Spine
Specialty Audible Torque Wrench Mfg by: Stryker Spine, Catalog number IS3002XLP, Non-sterile. Used to final tighten to 12 Nm the blocker of the XIA 3, Hooks, Monoaxial Screws, Rod to Rod Connectors a
Terminated
LXHNone listed
Nov 10, 2014DePuy Orthopaedics, Inc.
ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed inside a polyethylene bag
Terminated
LXHNone listed
Oct 10, 2014Orthohelix Surgical Designs Inc
MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside. Used during procedures to clear away bone and cartilage within the desired imp
Terminated
LXHNone listed

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