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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)
May 15, 2020TeDan Surgical Innovations LLC
PHANTOM CS QUICK START DISTRACTION SCREW, 16 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
Terminated
LXHNone listed
May 15, 2020TeDan Surgical Innovations LLC
PHANTOM CS QUICK START DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
Terminated
LXHNone listed
May 15, 2020TeDan Surgical Innovations LLC
PHANTOM CS QUICK START DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
Terminated
LXHNone listed
May 15, 2020TeDan Surgical Innovations LLC
PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
Terminated
LXHNone listed
May 15, 2020TeDan Surgical Innovations LLC
PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
Terminated
LXHNone listed
May 15, 2020TeDan Surgical Innovations LLC
3COR DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
Terminated
LXHNone listed
May 15, 2020TeDan Surgical Innovations LLC
3COR DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
Terminated
LXHNone listed
May 5, 2020Zimmer Biomet, Inc.
Vital MIS Spinal Fixation system implants VITAL MIS TAB BREAKER, Item Number 850M0055 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior
Terminated
LXHK183550
May 1, 2020Biomet
Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument Product Code: 14235
Terminated
LXHNone listed
Apr 3, 2020Pega Medical Inc.
Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip for the SLIM driver in orthopedic surgical procedures.
Terminated
LXHNone listed
Dec 19, 2019Zimmer Biomet, Inc.
ASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp Mode Number: 110032332 Product Usage: The device is a general orthopedic manual surgical instrument
Terminated
LXHNone listed
Dec 17, 2019Arthrex, Inc.
Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeting Guide
Terminated
LXHNone listed
Dec 6, 2019Encore Medical, Lp
EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part # 800-99-096
Open, Classified
LXHNone listed
Nov 12, 2019Aesculap Implant Systems LLC
ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.
Completed
LXHNone listed
Oct 25, 2019Zimmer Biomet, Inc.
Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM- Orthopedic manual surgical instrument Item Number: 475665
Terminated
LXHNone listed
Oct 25, 2019Zimmer Biomet, Inc.
Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual surgical instrument Item Number: 475660
Terminated
LXHNone listed
Oct 10, 2019Zimmer Biomet, Inc.
Various Surgical Instruments: Screws and Reamers, Item Nos. 00579104100 00579104200 00579104300 00579104400 00579105400 00597909526 00597909529 00597909532 00597909535 00597909538 00597909541 00597909
Terminated
LXHNone listed
Oct 7, 2019Smith & Nephew, Inc.
LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN InterTAN nails are indicated for fractures of the femur including: simple shaft fractures, comminuted shaft fractures, spiral
Terminated
LXHK122170
Oct 2, 2019Pega Medical Inc.
SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery
Terminated
LXHNone listed
Aug 6, 2019Zimmer Biomet, Inc.
ASI 2.0 Calcar Trimmer Shaft for Use with Biomet Rasp, Model Number 110032331
Terminated
LXHNone listed
May 28, 2019Zimmer Biomet, Inc.
K-Wire Trochar Tip, Model Number 212000008 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.
Terminated
LXHNone listed
Apr 18, 2019Zimmer Biomet, Inc.
Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-421930 System Domed Lateral Femoral Drill Guide Small
Terminated
LXHNone listed
Apr 18, 2019Zimmer Biomet, Inc.
Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-421060 Phase 3 Femoral Drill Guide Extra Small
Terminated
LXHNone listed
Apr 18, 2019Zimmer Biomet, Inc.
Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420324Phase 3 Femoral Drill Guide Extra Large
Terminated
LXHNone listed
Apr 18, 2019Zimmer Biomet, Inc.
Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420323 Phase 3 Femoral Drill Guide Large
Terminated
LXHNone listed
Apr 18, 2019Zimmer Biomet, Inc.
Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420322 Phase 3 Femoral Drill Guide Medium
Terminated
LXHNone listed
Apr 18, 2019Zimmer Biomet, Inc.
Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420321 Phase 3 Femoral Drill Guide Small
Terminated
LXHNone listed
Apr 1, 2019Zimmer Biomet, Inc.
Mobi-C 14mm Distraction Screw, Quick Start. Intended for cervical intervertebral disc replacement. Item Number: 0024-LDR TEDAN SURGICAL INNOVATIONS LLC DISTRIBUTED BY: LDR SPINE USA, INC., 13785 RESEA
Terminated
LXHNone listed
Feb 18, 2019TeDan Surgical Innovations LLC
DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.
Terminated
LXHNone listed
Feb 18, 2019TeDan Surgical Innovations LLC
DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.
Terminated
LXHNone listed
Feb 18, 2019TeDan Surgical Innovations LLC
D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior ap
Terminated
LXHNone listed
Feb 18, 2019TeDan Surgical Innovations LLC
D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior ap
Terminated
LXHNone listed
Jan 7, 2019Smith & Nephew, Inc.
SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
Terminated
LXHK123598
Nov 29, 2018OMNIlife science Inc.
OMNI K1 Broach Handle, Product Code HS-10054
Terminated
LXHNone listed
Nov 26, 2018Howmedica Osteonics Corp.
Reliance LITe Nerve Hook Bayoneted, 90, Blunt Tip, REF # 48066103 The blunt probe can be used as a conventional means of achieving nerve retraction. The bend at the proximal tip of the ring the disc
Terminated
LXHNone listed
Nov 2, 2018Howmedica Osteonics Corp.
Sterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm, REF 7650-2038A - Product Usage: Howmedica Osteonics Corp. (Stryker, Joint Reconstructive Division) Sterile Instrumentatio
Terminated
LXHNone listed
Oct 22, 2018Zimmer Biomet, Inc.
Zimmer Pressure Sentinel Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Item Number: 00-2228-024-00 Product Usage: A single use surgical instrument used during orthopaedic su
Terminated
LXHNone listed
Oct 22, 2018Zimmer Biomet, Inc.
Zimmer Natural Nail System - Tear Drop Guide Wire, 2.4 mm Diameter, 70 cm Length Item Number: 47-2490-098-01 Product Usage: A single use surgical instrument used during orthopaedic surgery for impla
Terminated
LXHNone listed
Oct 22, 2018Zimmer Biomet, Inc.
Zimmer Natural Nail System - Tear Drop Guide Wire, 3.0 mm Diameter, 70 cm Length Item Number: 47-2490-098-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for impla
Terminated
LXHNone listed
Oct 22, 2018Zimmer Biomet, Inc.
Zimmer Natural Nail System - Tear Drop Guide Wire, 2.4 mm Diameter, 100 cm Length Item Number: 47-2490-097-01 Product Usage: A single use surgical instrument used during orthopaedic surgery for impl
Terminated
LXHNone listed
Oct 22, 2018Zimmer Biomet, Inc.
Zimmer Natural Nail System - Tear Drop Guide Wire, 3.0 mm Diameter, 100 cm Length Item Number: 47-2490-097-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for impl
Terminated
LXHNone listed
Oct 22, 2018Zimmer Biomet, Inc.
Zimmer Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item Number: 47-2255-008-01 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of
Terminated
LXHNone listed
Oct 22, 2018Zimmer Biomet, Inc.
Zimmer Humeral Guide Wire - Ball Tip, 2.4 mm Diameter, 70 cm Length Item Number: 47-2255-008-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a p
Terminated
LXHNone listed
Oct 22, 2018Zimmer Biomet, Inc.
Zimmer ZMS Intramedullary Fixation Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item Number: 47-2237-038-00 Product Usage: A single use surgical instrument used during orthopaedic
Terminated
LXHNone listed
Oct 22, 2018Zimmer Biomet, Inc.
Zimmer ZMS Intramedullary Fixation Smooth Guide Wire, 3.0 mm Diameter, 100 cm Length Item Number: 47-2237-037-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for
Terminated
LXHNone listed
Oct 22, 2018Zimmer Biomet, Inc.
Zimmer ZMS Intramedullary Fixation Smooth Guide Wire, 2.4 mm Diameter, 100 cm Length Item Number: 47-2237-033-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for
Terminated
LXHNone listed
Oct 22, 2018Zimmer Biomet, Inc.
Zimmer M/DN Intramedullary Fixation Humeral Guide Wire - Bullet Tip, 2.4 mm Diameter, 70 cm Length Item Number: 00-2255-026-00 Product Usage: A single use surgical instrument used during orthopaedi
Terminated
LXHNone listed
Oct 22, 2018Zimmer Biomet, Inc.
Zimmer M/DN Intramedullary Fixation Humeral Guide Wire - Smooth, 2.4 mm Diameter, 70 cm Length Item Number: 00-2255-025-00 Product Usage: A single use surgical instrument used during orthopaedic sur
Terminated
LXHNone listed
Oct 22, 2018Zimmer Biomet, Inc.
Zimmer Pressure Sentinel Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Item Number: 00-2228-024-00 Product Usage: A single use surgical instrument used during orthopaedic sur
Terminated
LXHNone listed
Sep 28, 2018TriMed Inc.
TriMed Wrist Hook Dorsal Impactor, REF IMPCT-WHD; and TriMed Wrist Hook Volar Impactor, REF IMPCT-WHV, both nonsterile, Rx, The firm name on the labels is TriMed Inc., Santa Clarita, CA.
Open, Classified
LXHNone listed

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