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) |
|---|---|---|---|
| May 15, 2020 | TeDan 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 |
LXH | None listed |
| May 15, 2020 | TeDan 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 |
LXH | None listed |
| May 15, 2020 | TeDan 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 |
LXH | None listed |
| May 15, 2020 | TeDan 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 |
LXH | None listed |
| May 15, 2020 | TeDan 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 |
LXH | None listed |
| May 15, 2020 | TeDan 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 |
LXH | None listed |
| May 15, 2020 | TeDan 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 |
LXH | None listed |
| May 5, 2020 | Zimmer 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 |
LXH | K183550 |
| May 1, 2020 | Biomet Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument
Product Code: 14235 Terminated |
LXH | None listed |
| Apr 3, 2020 | Pega 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 |
LXH | None listed |
| Dec 19, 2019 | Zimmer 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 |
LXH | None listed |
| Dec 17, 2019 | Arthrex, Inc. Arthrex Fibulock Fibular Nail Instrument Set
Reusable non-sterile instruments
Outrigger Targeting Guide Terminated |
LXH | None listed |
| Dec 6, 2019 | Encore 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 |
LXH | None listed |
| Nov 12, 2019 | Aesculap 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 |
LXH | None listed |
| Oct 25, 2019 | Zimmer Biomet, Inc. Biomet Orthopedics Intramedullary Bone Saw Cam Assembly
14MM-
Orthopedic manual surgical instrument
Item Number: 475665 Terminated |
LXH | None listed |
| Oct 25, 2019 | Zimmer Biomet, Inc. Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual surgical instrument
Item Number: 475660 Terminated |
LXH | None listed |
| Oct 10, 2019 | Zimmer Biomet, Inc. Various Surgical Instruments: Screws and Reamers, Item Nos. 00579104100
00579104200
00579104300
00579104400
00579105400
00597909526
00597909529
00597909532
00597909535
00597909538
00597909541
00597909 Terminated |
LXH | None listed |
| Oct 7, 2019 | Smith & 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 |
LXH | K122170 |
| Oct 2, 2019 | Pega Medical Inc. SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery Terminated |
LXH | None listed |
| Aug 6, 2019 | Zimmer Biomet, Inc. ASI 2.0 Calcar Trimmer Shaft for Use with Biomet Rasp, Model Number 110032331 Terminated |
LXH | None listed |
| May 28, 2019 | Zimmer 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 |
LXH | None listed |
| Apr 18, 2019 | Zimmer 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 |
LXH | None listed |
| Apr 18, 2019 | Zimmer 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 |
LXH | None listed |
| Apr 18, 2019 | Zimmer Biomet, Inc. Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide:
Item Number: 32-420324Phase 3 Femoral Drill Guide Extra Large Terminated |
LXH | None listed |
| Apr 18, 2019 | Zimmer Biomet, Inc. Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide:
Item Number: 32-420323 Phase 3 Femoral Drill Guide Large Terminated |
LXH | None listed |
| Apr 18, 2019 | Zimmer Biomet, Inc. Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide:
Item Number: 32-420322 Phase 3 Femoral Drill Guide Medium Terminated |
LXH | None listed |
| Apr 18, 2019 | Zimmer Biomet, Inc. Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide:
Item Number: 32-420321 Phase 3 Femoral Drill Guide Small Terminated |
LXH | None listed |
| Apr 1, 2019 | Zimmer 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 |
LXH | None listed |
| Feb 18, 2019 | TeDan 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 |
LXH | None listed |
| Feb 18, 2019 | TeDan 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 |
LXH | None listed |
| Feb 18, 2019 | TeDan 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 |
LXH | None listed |
| Feb 18, 2019 | TeDan 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 |
LXH | None listed |
| Jan 7, 2019 | Smith & Nephew, Inc. SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613 Terminated |
LXH | K123598 |
| Nov 29, 2018 | OMNIlife science Inc. OMNI K1 Broach Handle, Product Code HS-10054 Terminated |
LXH | None listed |
| Nov 26, 2018 | Howmedica 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 |
LXH | None listed |
| Nov 2, 2018 | Howmedica 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 |
LXH | None listed |
| Oct 22, 2018 | Zimmer 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 |
LXH | None listed |
| Oct 22, 2018 | Zimmer 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 |
LXH | None listed |
| Oct 22, 2018 | Zimmer 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 |
LXH | None listed |
| Oct 22, 2018 | Zimmer 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 |
LXH | None listed |
| Oct 22, 2018 | Zimmer 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 |
LXH | None listed |
| Oct 22, 2018 | Zimmer 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 |
LXH | None listed |
| Oct 22, 2018 | Zimmer 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 |
LXH | None listed |
| Oct 22, 2018 | Zimmer 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 |
LXH | None listed |
| Oct 22, 2018 | Zimmer 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 |
LXH | None listed |
| Oct 22, 2018 | Zimmer 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 |
LXH | None listed |
| Oct 22, 2018 | Zimmer 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 |
LXH | None listed |
| Oct 22, 2018 | Zimmer 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 |
LXH | None listed |
| Oct 22, 2018 | Zimmer 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 |
LXH | None listed |
| Sep 28, 2018 | TriMed 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 |
LXH | None listed |
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