Panels › Orthopedic › Product code HXX · Class 1
Screwdriver
Regulation 888.4540
0510(k)s in 12 months (4 all time)
0recalls in 12 months (32 all time)
6recalls that name a 510(k)
Top companies in HXX
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 28, 2024 | Synthes (USA) Products LLC STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants during orthopaedic surgery.
Part Number: 03.130.010 Open, Classified |
HXX | None listed |
| Oct 25, 2021 | Aesculap Implant Systems LLC MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441 Terminated |
HXX | None listed |
| Apr 15, 2021 | Flower Orthopedics Corporation T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intended to be used to insert screws with T25 driving features, which includes screws with diameters of 5.5 Terminated |
HXX | None listed |
| May 28, 2019 | Zimmer Biomet, Inc. DVR Crosslock ePAK Screw Driver, Model Number 212000002
Product Usage:
These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma. Terminated |
HXX | None listed |
| Mar 14, 2019 | Trilliant Surgical, LLC Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal. Terminated |
HXX | None listed |
| May 4, 2018 | Synthes (USA) Products LLC Synthes Torque Limiting Handle, Part Number 03.231.013
This device is used in systems indicated for fracture fixation. Terminated |
HXX | None listed |
| Jun 1, 2016 | Orthofix, Inc Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set screw into a spinal fixation construct. Rx Only Provided non Sterile. Terminated |
HXX | K153428 |
| Apr 26, 2016 | Greatbatch Medical Torque Limiting Screwdriver:
Greatbatch Medical, Torque Limiting Driver, Non Sterile, Rx Only.
PRECIMED, Non Sterile.
Zimmer, Non Sterile, Rx Only.
Screwdriver:
Customer Number/Model:
804-03-03 Terminated |
HXX | None listed |
| Jun 17, 2014 | Ebi, Llc Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System. Terminated |
HXX | None listed |
| Jan 30, 2014 | Medtronic Sofamor Danek USA Inc SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc.
Screwdriver - orthopedic manual surgical instrument. Terminated |
HXX | None listed |
| Nov 27, 2013 | Ebi, Llc Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ 07054
The Polaris Spinal Systems is a non-cervical spinal fixation device intended for im Terminated |
HXX | None listed |
| Sep 14, 2013 | Medtronic Sofamor Danek USA Inc T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA,
Product Usage:
The non-sterile T8 Removal Diriver is used with the Spire and Spire Z Spinal System in conjunction with the set screwdriver to remove the impl Terminated |
HXX | None listed |
| Aug 13, 2013 | SpineFrontier, Inc. Invue Solid Driver, Tipped, AO. Part Number: 11-70083.
Allows the user to retain the screw when changing axis of insertion during fixation of spinal intervertebral. Terminated |
HXX | K121060 |
| Aug 8, 2013 | SpineFrontier, Inc. Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k) clearance number K121060.
The Invue Driver is an instr Terminated |
HXX | None listed |
| Aug 8, 2013 | SpineFrontier, Inc. Rev E PedFuse Return Screw Inserter, Part Number: 11-80030
Screw inserters are instruments which capture, hold and drive pedicle screw assemblies. There is a capturing feature that engages and holds Terminated |
HXX | K092420 |
| Jul 5, 2013 | SpineFrontier, Inc. InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly
Product Usage:
Inserters are stainless steel instruments that have an inner shaft. The left and right inserters are used in combination Terminated |
HXX | None listed |
| Mar 15, 2013 | Ebi, Llc Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-cervical, pedicle screw spinal fixation device. Terminated |
HXX | None listed |
| Dec 17, 2012 | Ebi, Llc Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178 Terminated |
HXX | None listed |
| Sep 28, 2012 | Biomet, Inc. Optilock T15 AO Driver (3.5mm).
Intended Use: The OptiLock Upper Extremity Plating System is intended for fixation of fractures and osteotomies. The System is intended for fractures and fracture disl Terminated |
HXX | None listed |
| Sep 28, 2012 | Biomet, Inc. Optilock 2.7 mm Screw Inserter.
Intended Use: The OptiLock Upper Extremity Plating System is intended for fixation of fractures and osteotomies. The System is intended for fractures and fracture disl Terminated |
HXX | None listed |
| Oct 13, 2011 | Interventional Spine Inc PERPOS Driver; Catalog # 6112
Interventional Spine, Inc.
A cannulated, driver to be used over a K-wire to engage the head of the 4.5mm BONE-LOK PLS Implant (LSW-45-3040) and drive it into the bone. T Terminated |
HXX | None listed |
| Oct 13, 2011 | Interventional Spine Inc Reusable BONE-LOK PLS System; Catalog #'s: 9039-01 and 9039-02.
Interventional Spine, Inc.
A sterile kit used to stabilize the spine as an aid to fusion through immobilization of the facet joints. S Terminated |
HXX | None listed |
| Oct 13, 2011 | Interventional Spine Inc PERPOS PLS System, Single Use; CATALOG #'s 9045-01 & 9045-02.
Interventional Spine, Inc.
A sterile kit used to stabilize the spine as an aid to fusion through immobilization of the facet joints. Terminated |
HXX | None listed |
| Jul 6, 2011 | Zimmer Inc. Pathfinder NXT Closure top driver - short, REF 3566-2, Zimmer Inc., Warsaw, IN
Product Usage: The Closure Top Driver is used in conjunction with compressors, distractors, and reducers, as needed, to Terminated |
HXX | K100845 |
| Jul 6, 2011 | Zimmer Inc. Pathfinder NXT Closure top driver - long, REF 3566-1, Zimmer Inc., Warsaw, IN
Product Usage: The Closure Top Driver is used in conjunction with compressors, distractors, and reducers, as needed, to Terminated |
HXX | K100845 |
| Sep 22, 2010 | Wright Medical Technology Inc DRIVER STAR #8 CANNULATED DART-FIRE (TM), COMPRESSION SCREW, SIZE: #8, REF: DSDS-0008, 1 EACH, Rx ONLY, NON-STERILE, EC REP Wright Medical EMEA, Krijgsman 11, 1186 DM Amstelveen, The Netherlands, Wri Terminated |
HXX | None listed |
| Jun 26, 2009 | Ascension Orthopedics, Inc Normed TX 8 Driver, Non-Cannulated (used with the Ascension Total Foot System); Catalog #503004268; distributed by Ascension Orthopedics, Inc., Austin, TX 78754.
Orthopedic manual surgical screwdriv Terminated |
HXX | K022324 K022325 |
| Sep 19, 2008 | Stryker Spine Reflex Revision Screwdriver Inner Shaft is a orthopedic manual surgical instrument that is a nonpowered, hand held device intended for medical purposes to manipulate tissue, or for use with other devi Terminated |
HXX | None listed |
| Sep 16, 2008 | Stryker Howmedica Osteonics Corp. Gammas Set Screwdriver Instrument Set, Basic Stryker Trauma GmbH, Germany; Distributed by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 - Orthopedic Device. The Gamma3 Locking Nail Terminated |
HXX | None listed |
| Sep 16, 2008 | Stryker Howmedica Osteonics Corp. Gamma 3 System Set Screwdriver, Flexible Shaft; 4mm, This product is non-sterile Stryker Trauma GmbH, Germany; Distributed by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 - Orthop Terminated |
HXX | None listed |
| Feb 23, 2006 | Medtronic Sofamor Danek Instrument Manufacturing Holt Probe Round Straight Terminated |
HXX | None listed |
| Dec 28, 2005 | Medtronic Sofamor Danek Instrument Manufacturing Atlantis Anterior Cervical Plate System Screw Driver, Part number 876-482 Terminated |
HXX | None listed |
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