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) |
|---|---|---|---|
| Mar 27, 2026 | Waldemar Link GmbH & Co. KG (Mfg Site) Embrace Drill Tower, Standard/Lateral (25mm);
Item Number: 645-081/63; Open, Classified |
HTW | None listed |
| Mar 27, 2026 | Waldemar Link GmbH & Co. KG (Mfg Site) Embrace Drill Tower, Wedged (25mm);
Item Number: 645-081/62; Open, Classified |
HTW | None listed |
| Mar 6, 2024 | Waldemar Link GmbH & Co. KG (Mfg Site) Embrace Drill Tower, Standard/Lateral (25mm) Open, Classified |
HTW | None listed |
| Mar 6, 2024 | Waldemar Link GmbH & Co. KG (Mfg Site) Embrace Drill Tower, Wedged (25mm) Open, Classified |
HTW | None listed |
| Sep 1, 2021 | Flower Orthopedics Corporation Flower Lag Screw Kit 2.7 mm-intended to be used with 2.7mm lag screws and can be used with any plate that as part of the Flower Small and Medium Implant Set, Flower Ankle Plating Set , Flower Rear Foo Terminated |
HTW | None listed |
| Sep 1, 2021 | Flower Orthopedics Corporation Flower Drill Bit Kit 2.7mm- The Drill Bit Kit, 2.7mm (DBK 027) is intended to be used with solid 2.7mm screws and can be used with any the Flower Small and Medium Implant Set Flower Ankle Plating Se Terminated |
HTW | None listed |
| Sep 1, 2021 | Flower Orthopedics Corporation Flower Drill Bit Kit 2.4 mm-intended to be used with solid 2.4mm screws and can be used with any plate as part of the Flower Small and Medium Implant Set and uses the small locking mechanism.
Catalog Terminated |
HTW | None listed |
| Sep 1, 2021 | Flower Orthopedics Corporation Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that has been cleared as part of the Flower Small and Medium Implant Set and uses the small lo Terminated |
HTW | None listed |
| Jul 30, 2021 | Paragon 28, Inc. Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection
p28 P99-110-4630 Terminated |
HTW | None listed |
| Feb 24, 2021 | Arthrex, Inc. Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures. Terminated |
HTW | None listed |
| Dec 17, 2020 | Biomet, Inc. RingLoc+ Quick Connect Drill Bit, Item numbers 31-323215,
31-323220, 31-323230, 31-323240 - Product Usage: Bit, Drill. Terminated |
HTW | None listed |
| Nov 3, 2020 | NEOSTEO Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery. Terminated |
HTW | None listed |
| Oct 10, 2019 | Trilliant Surgical, LLC 3.5mm Aresenal Screw Drill Bit , Ref: 330-35-001, Qty. 70, Rx Only, Non-Sterile, UDI: (01)00812926029696 - Product Usage: A drill bit facilitates implant insertion Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill, contra-angle, 1.5x85mm, Item Number ST502015706 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill, 3.2x145mm, AO, Item Number ST502015650 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill, cannulated, 4x90mm, round shaft, Item Number ST502015640 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill, cannulated, 3.5x90mm, round shaft, Item Number ST502015635 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill, cannulated, 3x90mm, AO, Item Number ST502015631 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill, cannulated, 3x90mm, round shaft, Item Number ST502015630 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill, cannulated, 2.8x120mm, AO, Item Number ST502015628 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill, cannulated, 2x95mm, AO, Item Number ST502015623 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill, cannulated, 2.5x95mm, AO, Item Number ST502015621 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill, cannulated, 2.5x95mm, round shaft, Item Number ST502015620 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill, cannulated, 2x95mm, round shaft, Item Number ST502015619 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill, cannulated, 4x150mm, AO, Item Number ST502015403 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill, cannulated, 4x120mm, AO, Item Number ST502015402 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill, 2.7x125mm, AO , Item Number ST502015217 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill for 3.5mm screw, 2.5x120mm, AO, Item Number ST502015216 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill for 2.7mm screw, 2x120mm, AO, Item Number ST502015212 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill for 2.7mm screw, 2x100mm, AO, Item Number ST502015208 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill for 2.7mm screw, 23mm stop, 2x103mm, AO, Item Number ST502015207 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill for 2.7mm screw, 20mm stop, 2x105mm, Stryker, Item Number ST502015206 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill, contra-angle, 1.5x85mm, Item Number 502015706 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill, 3.2x145mm, AO, Item Number 502015650 Terminated |
HTW | K123347 |
| Apr 8, 2019 | Zimmer GmbH Drill, cannulated, 4x90mm, round shaft, Item Number 502015640 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH V-TEK", IVP step drill 2.5-3.9x124mm, 16mm stop, AO, Item Number 502015638 Terminated |
HTW | K152312 |
| Apr 8, 2019 | Zimmer GmbH V-TEK", IVP step drill 2.5-3.9x124mm, 16mm stop, contra-angle, Item Number 502015637 Terminated |
HTW | K152312 |
| Apr 8, 2019 | Zimmer GmbH V-TEK", IVP step drill 2-3.4x124mm, 16mm stop, AO, Item Number 502015636 Terminated |
HTW | K152312 |
| Apr 8, 2019 | Zimmer GmbH Drill, cannulated, 3.5x90mm, round shaft, Item Number 502015635 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH V-TEK", IVP step drill 2-3.4x124mm, 16mm stop, contra-angle, Item Number 502015634 Terminated |
HTW | K152312 |
| Apr 8, 2019 | Zimmer GmbH Drill, cannulated, 3x90mm, AO, Item Number 502015631 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill, cannulated, 3x90mm, round shaft, Item Number 502015630 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill, cannulated, 2.8x150mm, AO, Item Number 502015629 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill, cannulated, 2.8x120mm, AO, Item Number 502015628 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill, cannulated, 2x95mm, AO, Item Number 502015623 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill, cannulated, 2.5x95mm, AO, Item Number 502015621 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill, cannulated, 2.5x95mm, round shaft, Item Number 502015620 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill, cannulated, 2x95mm, round shaft, Item Number 502015619 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill, cannulated, 4x150mm, AO, Item Number 502015403 Terminated |
HTW | None listed |
| Apr 8, 2019 | Zimmer GmbH Drill, cannulated, 4x120mm, AO, Item Number 502015402 Terminated |
HTW | None listed |
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