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)
Top companies in HTW
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer GmbH | 0 | 60 |
| Stryker Howmedica Osteonics | 0 | 8 |
| Exactech, Inc. | 0 | 6 |
| Flower Orthopedics Corporation | 0 | 4 |
| Waldemar Link GmbH & Co. KG (Mfg Site) | 0 | 4 |
| AAP Implantate Ag | 0 | 2 |
| The Anspach Effort, Inc. | 0 | 2 |
| Biomet, Inc. | 0 | 2 |
| Intelifuse Inc | 0 | 2 |
| Interventional Spine Inc | 0 | 2 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 8, 2019 | Zimmer GmbH Drill for 3.5mm screw, 2.5x125mm, stryker, Item Number 502015218 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill, 2.7x125mm, AO, Item Number 502015217 Terminated |
HTW | K123347 |
| Apr 8, 2019 | Zimmer GmbH Drill for 3.5mm screw, 2.5x120mm, AO, Item Number 502015216 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Osteofresh arthrodesis drill, 2x70mm, center tip, AO, 10mm stop, Item Number 502015213 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill for 2.7mm screw, 2x120mm, AO, Item Number 502015212 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill for 2.7mm screw, 2x125mm, Stryker, Item Number 502015211 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill for 2.7mm screw, 2x100mm, AO, Item Number 502015208 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill for 2.7mm screw, 23mm stop, 2x103mm, AO, Item Number 502015207 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill for 2.7mm screw, 20mm stop, 2x105mm, Stryker, Item Number 502015206 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill, 26mm stop, 1.4x81mm, AO, Item Number 502015146 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill, 26mm stop, 1.4x94mm, stryker, Item Number 502015145 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill, 2.5x135mm, AO, Item Number 502015142 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill, 2.5x87mm, AO, Item Number 502015137 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill, 2.5x94mm, Stryker, Item Number 502015136 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill, 19mm stop, 1.9x87mm, AO, Item Number 502015131 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill, 26mm stop, 1.9x94mm, Stryker, Item Number 502015130 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill, 26mm stop, 1.4x81mm, AO, Item Number 502015124 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill, 26mm stop, 1.4x94mm, Stryker, Item Number 502015120 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill, 15mm stop, 1x76mm, AO , Item Number 502015115 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill, 15mm stop, 1x83mm, Stryker, Item Number 502015114 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill Sys2.7, 2x103mm, AO, Item Number 502015107 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill Sys 2.7, 2x105mm, stryker, Item Number 502015106 Terminated |
HTW | None listed |
| Jan 25, 2019 | AAP Implantate Ag INTEGRA, Drill CS 4.0, quick coupling single use, REF 430425 Terminated |
HTW | None listed |
| Jan 25, 2019 | AAP Implantate Ag INTEGRA, Drill CS 4.5, quick coupling single use, REF 430453 Terminated |
HTW | None listed |
| Mar 26, 2018 | Tornier, 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 |
HTW | K082754 |
| May 22, 2017 | MicroAire 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 |
HTW | None listed |
| May 26, 2016 | Biomet, Inc. Various trauma and sports medicine instruments and implants.
Bit, drill. Terminated |
HTW | None listed |
| May 23, 2016 | Synthes (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 |
HTW | None listed |
| May 23, 2016 | Synthes (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 |
HTW | None listed |
| Aug 24, 2015 | Trilliant 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 |
HTW | K081510 |
| Jun 4, 2015 | Synthes, 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 |
HTW | None listed |
| Jan 11, 2014 | The Anspach Effort, Inc. Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only Terminated |
HTW | None listed |
| Nov 27, 2013 | Synthes 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 |
HTW | None listed |
| Oct 10, 2013 | Cayenne 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 |
HTW | None listed |
| Jul 1, 2013 | Surgical 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 |
HTW | None listed |
| May 24, 2013 | Zimmer, Inc. NEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mm.
Used to prepare cylindrical holes in the native tibia. Terminated |
HTW | K012866 K020295 |
| May 1, 2013 | Stryker 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 |
HTW | None listed |
| Mar 22, 2013 | Orthohelix 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 |
HTW | None listed |
| Nov 19, 2012 | Linvatec 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 |
HTW | None listed |
| Nov 19, 2012 | Linvatec 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 |
HTW | None listed |
| Sep 11, 2012 | Exactech, 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 |
HTW | None listed |
| Sep 11, 2012 | Exactech, 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 |
HTW | None listed |
| Sep 11, 2012 | Exactech, 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 |
HTW | None listed |
| Sep 11, 2012 | Exactech, 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 |
HTW | None listed |
| Sep 11, 2012 | Exactech, 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 |
HTW | None listed |
| Sep 11, 2012 | Exactech, 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 |
HTW | None listed |
| Jul 25, 2012 | The 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 |
HTW | K061297 K974025 |
| Jun 6, 2012 | Smith & Nephew Inc 2.7 MM DRILL BIT, REF 71173503, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Orthopedic surgical device. Terminated |
HTW | None listed |
| Jun 6, 2012 | Smith & Nephew Inc 2.0 MM DRILL BIT, REF 71173501, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Orthopedic surgical device. Terminated |
HTW | None listed |
| Jan 11, 2012 | Synthes 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 |
HTW | None listed |
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