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) |
|---|---|---|---|
| Jan 6, 2017 | DePuy Orthopaedics, Inc. DePuy Synthes
various orthopedic instruments modified by U.S. Distributors
These instruments are used in various orthopedic procedures Terminated |
LXH | None listed |
| Dec 22, 2016 | Flower Orthopedics Corporation Cannulated Drill bit 2.0mm and 2.6 mm; Used in conjunction with the Flower Bone Screw Set. Terminated |
LXH | None listed |
| Dec 14, 2016 | MEDLINE 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 |
LXH | None listed |
| Dec 14, 2016 | MEDLINE 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 |
LXH | None listed |
| Dec 14, 2016 | MEDLINE 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 |
LXH | None listed |
| Dec 14, 2016 | MEDLINE 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 |
LXH | None listed |
| Dec 14, 2016 | MEDLINE 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 |
LXH | None listed |
| Dec 2, 2016 | Stryker 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 |
LXH | None listed |
| Nov 22, 2016 | Amendia, 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 |
LXH | None listed |
| Nov 19, 2016 | Synthes (USA) Products LLC Extraction Hook - Sterile for TI Cannulated Nails Terminated |
LXH | None listed |
| Nov 15, 2016 | Robert 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 |
LXH | None listed |
| Nov 4, 2016 | Thayer 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 |
LXH | None listed |
| Oct 19, 2016 | Greatbatch 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 |
LXH | None listed |
| Oct 14, 2016 | Zimmer 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 |
LXH | None listed |
| Oct 5, 2016 | LDR 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 |
LXH | K082262 K090507 +2 |
| Sep 23, 2016 | Cardinal Health 200, LLC V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX. Terminated |
LXH | None listed |
| Aug 31, 2016 | Limacorporate S.p.A SMR allen wrench 5 mm, product code 9013.50.210 Terminated |
LXH | None listed |
| Aug 2, 2016 | Zimmer 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 |
LXH | None listed |
| Aug 2, 2016 | Zimmer 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 |
LXH | None listed |
| Aug 2, 2016 | Zimmer 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 |
LXH | None listed |
| Aug 2, 2016 | Zimmer 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 |
LXH | None listed |
| May 26, 2016 | Biomet, Inc. Various trauma and sports medicine instruments and implants.
Orthopedic manual surgical instrument. Terminated |
LXH | None listed |
| Feb 25, 2016 | Biomet, Inc. HipLOC CHS Plate/Lag Screw Introducer Terminated |
LXH | None listed |
| Jan 5, 2016 | Biomet U.K., Ltd. Oxford Unicompartmental Knee Phase 3 Shim Size 1
Product Usage:
Instruments for use with the Oxford Uni Partial Knee System Terminated |
LXH | None listed |
| Jan 5, 2016 | Biomet U.K., Ltd. Oxford Unicompartmental Knee Phase 3 Shim Size 2
Product Usage:
Instruments for use with the Oxford Uni Partial Knee System Terminated |
LXH | None listed |
| Jan 5, 2016 | Biomet U.K., Ltd. Oxford Unicompartmental Knee Phase 3 Shim Size 3
Product Usage:
Instruments for use with the Oxford Uni Partial Knee System Terminated |
LXH | None listed |
| Jan 5, 2016 | Biomet U.K., Ltd. Oxford Partial Knee System Femoral Slap Hammer
Product Usage:
Instruments for use with the Oxford Uni Partial Knee System Terminated |
LXH | None listed |
| Jan 5, 2016 | Biomet U.K., Ltd. Oxford Knee System Tibial Resector Body Tube & Guides
Product Usage:
Instruments for use with the Oxford Uni Partial Knee System Terminated |
LXH | None listed |
| Dec 18, 2015 | Stryker 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 |
LXH | None listed |
| Dec 10, 2015 | Zimmer, 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 |
LXH | None listed |
| Dec 10, 2015 | Zimmer, 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 |
LXH | None listed |
| Nov 5, 2015 | Stryker Spine Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number 48590100. Manual Surgical Instrument. Terminated |
LXH | None listed |
| Oct 7, 2015 | DePuy 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 |
LXH | None listed |
| Oct 5, 2015 | Synthes (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 |
LXH | None listed |
| Sep 3, 2015 | Synthes (USA) Products LLC Inserter for Titanium Elastic Nails (TEN), orthopedic device Terminated |
LXH | None listed |
| May 29, 2015 | Zimmer, Inc. PRI Femoral Impactor Block for knee prosthesis surgery.
Orthopedic Manual Surgical Instrument Terminated |
LXH | None listed |
| Apr 27, 2015 | Zimmer Gmbh Anatomical Shoulder Handle for Rasp
Item: 01.04233.000
Used during total joint arthroplasty of the shoulder. Terminated |
LXH | None listed |
| Apr 21, 2015 | Captiva Spine, Inc Captiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers). Terminated |
LXH | None listed |
| Apr 7, 2015 | Bacterin 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 |
LXH | None listed |
| Mar 31, 2015 | DePuy Orthopaedics, Inc. RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instrument for hip implantation. Terminated |
LXH | None listed |
| Mar 10, 2015 | Synthes, 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 |
LXH | None listed |
| Jan 14, 2015 | SpineFrontier, Inc. lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164 Terminated |
LXH | None listed |
| Jan 12, 2015 | DePuy 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 |
LXH | None listed |
| Jan 5, 2015 | DePuy 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 |
LXH | None listed |
| Jan 5, 2015 | DePuy 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 |
LXH | None listed |
| Jan 5, 2015 | DePuy 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 |
LXH | None listed |
| Jan 5, 2015 | DePuy 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 |
LXH | None listed |
| Dec 16, 2014 | Stryker 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 |
LXH | None listed |
| Nov 10, 2014 | DePuy Orthopaedics, Inc. ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed inside a polyethylene bag Terminated |
LXH | None listed |
| Oct 10, 2014 | Orthohelix 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 |
LXH | None listed |
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