ClearanceBrief
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)
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Top companies in HXX

DateFirm and productCodeLinked 510(k)
May 28, 2024Synthes (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
HXXNone listed
Oct 25, 2021Aesculap Implant Systems LLC
MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441
Terminated
HXXNone listed
Apr 15, 2021Flower 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
HXXNone listed
May 28, 2019Zimmer 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
HXXNone listed
Mar 14, 2019Trilliant Surgical, LLC
Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal.
Terminated
HXXNone listed
May 4, 2018Synthes (USA) Products LLC
Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used in systems indicated for fracture fixation.
Terminated
HXXNone listed
Jun 1, 2016Orthofix, 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
HXXK153428
Apr 26, 2016Greatbatch 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
HXXNone listed
Jun 17, 2014Ebi, Llc
Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System.
Terminated
HXXNone listed
Jan 30, 2014Medtronic Sofamor Danek USA Inc
SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc. Screwdriver - orthopedic manual surgical instrument.
Terminated
HXXNone listed
Nov 27, 2013Ebi, 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
HXXNone listed
Sep 14, 2013Medtronic 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
HXXNone listed
Aug 13, 2013SpineFrontier, 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
HXXK121060
Aug 8, 2013SpineFrontier, 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
HXXNone listed
Aug 8, 2013SpineFrontier, 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
HXXK092420
Jul 5, 2013SpineFrontier, 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
HXXNone listed
Mar 15, 2013Ebi, 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
HXXNone listed
Dec 17, 2012Ebi, Llc
Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178
Terminated
HXXNone listed
Sep 28, 2012Biomet, 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
HXXNone listed
Sep 28, 2012Biomet, 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
HXXNone listed
Oct 13, 2011Interventional 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
HXXNone listed
Oct 13, 2011Interventional 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
HXXNone listed
Oct 13, 2011Interventional 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
HXXNone listed
Jul 6, 2011Zimmer 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
HXXK100845
Jul 6, 2011Zimmer 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
HXXK100845
Sep 22, 2010Wright 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
HXXNone listed
Jun 26, 2009Ascension 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
HXXK022324
K022325
Sep 19, 2008Stryker 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
HXXNone listed
Sep 16, 2008Stryker 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
HXXNone listed
Sep 16, 2008Stryker 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
HXXNone listed
Feb 23, 2006Medtronic Sofamor Danek Instrument Manufacturing
Holt Probe Round Straight
Terminated
HXXNone listed
Dec 28, 2005Medtronic Sofamor Danek Instrument Manufacturing
Atlantis Anterior Cervical Plate System Screw Driver, Part number 876-482
Terminated
HXXNone listed

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