ClearanceBrief
Panels › Orthopedic › Product code HTW · Class 1

Bit, Drill

Regulation 888.4540

0510(k)s in 12 months (11 all time)
2recalls in 12 months (114 all time)
12recalls that name a 510(k)
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Top companies in HTW

DateFirm and productCodeLinked 510(k)
Apr 8, 2019Zimmer GmbH
Drill for 3.5mm screw, 2.5x125mm, stryker, Item Number 502015218
Terminated
HTWNone listed
Apr 8, 2019Zimmer GmbH
Drill, 2.7x125mm, AO, Item Number 502015217
Terminated
HTWK123347
Apr 8, 2019Zimmer GmbH
Drill for 3.5mm screw, 2.5x120mm, AO, Item Number 502015216
Terminated
HTWNone listed
Apr 8, 2019Zimmer GmbH
Osteofresh arthrodesis drill, 2x70mm, center tip, AO, 10mm stop, Item Number 502015213
Terminated
HTWNone listed
Apr 8, 2019Zimmer GmbH
Drill for 2.7mm screw, 2x120mm, AO, Item Number 502015212
Terminated
HTWNone listed
Apr 8, 2019Zimmer GmbH
Drill for 2.7mm screw, 2x125mm, Stryker, Item Number 502015211
Terminated
HTWNone listed
Apr 8, 2019Zimmer GmbH
Drill for 2.7mm screw, 2x100mm, AO, Item Number 502015208
Terminated
HTWNone listed
Apr 8, 2019Zimmer GmbH
Drill for 2.7mm screw, 23mm stop, 2x103mm, AO, Item Number 502015207
Terminated
HTWNone listed
Apr 8, 2019Zimmer GmbH
Drill for 2.7mm screw, 20mm stop, 2x105mm, Stryker, Item Number 502015206
Terminated
HTWNone listed
Apr 8, 2019Zimmer GmbH
Drill, 26mm stop, 1.4x81mm, AO, Item Number 502015146
Terminated
HTWNone listed
Apr 8, 2019Zimmer GmbH
Drill, 26mm stop, 1.4x94mm, stryker, Item Number 502015145
Terminated
HTWNone listed
Apr 8, 2019Zimmer GmbH
Drill, 2.5x135mm, AO, Item Number 502015142
Terminated
HTWNone listed
Apr 8, 2019Zimmer GmbH
Drill, 2.5x87mm, AO, Item Number 502015137
Terminated
HTWNone listed
Apr 8, 2019Zimmer GmbH
Drill, 2.5x94mm, Stryker, Item Number 502015136
Terminated
HTWNone listed
Apr 8, 2019Zimmer GmbH
Drill, 19mm stop, 1.9x87mm, AO, Item Number 502015131
Terminated
HTWNone listed
Apr 8, 2019Zimmer GmbH
Drill, 26mm stop, 1.9x94mm, Stryker, Item Number 502015130
Terminated
HTWNone listed
Apr 8, 2019Zimmer GmbH
Drill, 26mm stop, 1.4x81mm, AO, Item Number 502015124
Terminated
HTWNone listed
Apr 8, 2019Zimmer GmbH
Drill, 26mm stop, 1.4x94mm, Stryker, Item Number 502015120
Terminated
HTWNone listed
Apr 8, 2019Zimmer GmbH
Drill, 15mm stop, 1x76mm, AO , Item Number 502015115
Terminated
HTWNone listed
Apr 8, 2019Zimmer GmbH
Drill, 15mm stop, 1x83mm, Stryker, Item Number 502015114
Terminated
HTWNone listed
Apr 8, 2019Zimmer GmbH
Drill Sys2.7, 2x103mm, AO, Item Number 502015107
Terminated
HTWNone listed
Apr 8, 2019Zimmer GmbH
Drill Sys 2.7, 2x105mm, stryker, Item Number 502015106
Terminated
HTWNone listed
Jan 25, 2019AAP Implantate Ag
INTEGRA, Drill CS 4.0, quick coupling single use, REF 430425
Terminated
HTWNone listed
Jan 25, 2019AAP Implantate Ag
INTEGRA, Drill CS 4.5, quick coupling single use, REF 430453
Terminated
HTWNone listed
Mar 26, 2018Tornier, Inc
AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis Humeral Nail system is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures o
Terminated
HTWK082754
May 22, 2017MicroAire Surgical Instruments, LLC
SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054-010, STERILE This product line is intended for use in orthopaedic surgery (large and small bone surgeries) to cut bone
Terminated
HTWNone listed
May 26, 2016Biomet, Inc.
Various trauma and sports medicine instruments and implants. Bit, drill.
Terminated
HTWNone listed
May 23, 2016Synthes (USA) Products LLC
3.2 mm three-fluted Radiolucent Drill Bit/Needle Point/145 mm Sterile Product Usage: The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Fem
Terminated
HTWNone listed
May 23, 2016Synthes (USA) Products LLC
3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S Product Usage: Usage: The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral
Terminated
HTWNone listed
Aug 24, 2015Trilliant Surgical Ltd.
3.0/4.0 Cannulated Drill Bit; a component of the Tiger Cannulated Screw System The Tiger Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis and o
Terminated
HTWK081510
Jun 4, 2015Synthes, Inc.
3.2 mm Cannulated Drill Bit/ QC 170 mm 2.7 Cannulated Drill Bit/ QC 160 mm 2.0 mm Cannulated Drill Bit / QC 150 mm there is no indication for Synthes Cannulated Drill Bits which is used with the Synt
Terminated
HTWNone listed
Jan 11, 2014The Anspach Effort, Inc.
Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only
Terminated
HTWNone listed
Nov 27, 2013Synthes USA HQ, Inc.
Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of large bones and large bone fragments and for slipped capital femoral epiphysis, pediatric femoral neck frac
Terminated
HTWNone listed
Oct 10, 2013Cayenne Medical Inc.
Drill (Fluted-Hard Bone), for Quattro Link 2.9mm, labeled as: a. Quattro Spade Drill, for 2.9mm, Model Number CM-9300; b. Quattro Drill 2.4mm, Hard Bone, Model Number CM-9324
Terminated
HTWNone listed
Jul 1, 2013Surgical Instrument Service And Savings, Inc.
- Cannulated Drill Bit for Mini TightRope Ref. AR-8911DC Lot 122511 - Drill Bit, Straight Shank 2.7mm x 12.7cm Ref. 2318-027-00 Lot 122322 - Drill Bit, w/Depth Mark, Quick Coupling (Red) 2.0mm x 14
Terminated
HTWNone listed
May 24, 2013Zimmer, Inc.
NEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mm. Used to prepare cylindrical holes in the native tibia.
Terminated
HTWK012866
K020295
May 1, 2013Stryker Howmedica Osteonics Corp.
Stryker Howmedica Osteonics Corp. AxSOS System Instrument. The AxSOS Locking Plate System is designed to treat periarticular or intraarticular fractures of the Distal Femur, Proximal Humerus, Proxi
Terminated
HTWNone listed
Mar 22, 2013Orthohelix Surgical Designs Inc
Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill Bit. Intended to stabilize and aid in fixation of fractures.
Terminated
HTWNone listed
Nov 19, 2012Linvatec Corp. dba ConMed Linvatec
"***SENTINEL***Cannulated Drill Bit***S8585***8.5 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2009-02***". This drill bit is an eccentric mono-fluted cutting ed
Terminated
HTWNone listed
Nov 19, 2012Linvatec Corp. dba ConMed Linvatec
"***SENTINEL***Cannulated Drill Bit***S8580***8 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2012-03***". This drill bit is an eccentric mono-fluted cutting edge
Terminated
HTWNone listed
Sep 11, 2012Exactech, Inc.
REF 101-45-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 4.5mm***Use with 40mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantat
Terminated
HTWNone listed
Sep 11, 2012Exactech, Inc.
REF 101-45-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 4.5mm***Use with 30mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantat
Terminated
HTWNone listed
Sep 11, 2012Exactech, Inc.
REF 101-45-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 4.5mm***Use with 20mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantat
Terminated
HTWNone listed
Sep 11, 2012Exactech, Inc.
REF 101-05-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 3.2mm***Use with 40mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantat
Terminated
HTWNone listed
Sep 11, 2012Exactech, Inc.
REF 101-05-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 3.2mm***Use with 30mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantat
Terminated
HTWNone listed
Sep 11, 2012Exactech, Inc.
REF 101-05-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 3.2mm***Use with 20mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantat
Terminated
HTWNone listed
Jul 25, 2012The Anspach Effort, Inc.
.***ANSPACH***Sterile. REF SHD-4820DS***QTY: 1, 4.8 mm x 2mm Twist Drill with Depth Stop. Use with SHORT-HD Attachment ***RX Only Product Usage: Cutting and shaping bone including bones of the spin
Terminated
HTWK061297
K974025
Jun 6, 2012Smith & Nephew Inc
2.7 MM DRILL BIT, REF 71173503, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
Terminated
HTWNone listed
Jun 6, 2012Smith & Nephew Inc
2.0 MM DRILL BIT, REF 71173501, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
Terminated
HTWNone listed
Jan 11, 2012Synthes USA (HQ), Inc.
Synthes Drill Bit for 5.0mm Recon Screws with Large Quick Coupling. This orthopedic manual surgical instrument is a non powered hand-held device intended for medical purposes to manipulate tissue, or
Terminated
HTWNone listed

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