Product code HTW
- Device name
- Bit, Drill
- Medical specialty
- Orthopedic
- Device class
- 1
- Regulation number
- 888.4540
- Review panel
- OR
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K151661 | Renovo Life Hard Carbon Coated Drill Bit | Renovo Life, LLC | 2016-01-15 |
| K942906 | AGEE-WRISTJACK PRE-DRILL KIT | Hand Biomechanics Lab, Inc. | 1994-12-22 |
| K930339 | REAMER BIT | Neoligaments, Ltd. | 1993-08-06 |
| K915692 | CANNULATED DRILL BIT | W. L. Gore & Associates, Inc. | 1992-01-16 |
| K892903 | MITEK ANCHOR DRILL | Mitek Surgical Products, Inc. | 1989-10-06 |
| K870217 | FEMORAL CEMENT REMOVAL INSTRUMENTS | Kenneth J. Hoek, M.D., Inc. | 1987-02-06 |
| K863147 | GLENOID DRILL | Bowen & Company, Inc. | 1986-09-05 |
| K841629 | DRILL BIT | Plastafil, Inc. | 1984-08-27 |
| K834229 | BONE PLUGGING TOOL | Standard Surgical | 1984-01-10 |
| K831712 | SURGICAL DRILL BITS | Medical Specialists IN Packaging | 1983-07-07 |
| K820226 | UNIVERSALL DRILL GUIDE | Ortho Pared Instruments, Inc. | 1982-02-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08059386749203 | Orthopaedic Surgical Instruments | CITIEFFE SRL | 2026-10-23 |
| 00763000674397 | MSB Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | 2026-10-23 |
| 04719886913330 | Momentum Acetabular Cup System | UNITED ORTHOPEDIC CORP. | 2026-10-15 |
| 00889795150202 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2026-10-12 |
| 00889795150196 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2026-10-12 |
| 00889795150189 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2026-10-12 |
| 00889795150172 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2026-10-12 |
| 00889795150165 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2026-10-12 |
| 00889795150158 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2026-10-12 |
| 00889795150141 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2026-10-12 |
| 00810112598896 | TriLEAP | Synthes GmbH | 2026-02-10 |
| 00810112597455 | TriLEAP | Synthes GmbH | 2026-02-10 |
| 00810112597448 | TriLEAP | Synthes GmbH | 2026-01-09 |
| 00190446898757 | Arsenal Foot | Trilliant Surgical, LLC | 2025-07-01 |
| 00190446898764 | Arsenal Foot | Trilliant Surgical, LLC | 2025-07-01 |
| 00190446898771 | Arsenal Foot | Trilliant Surgical, LLC | 2025-07-01 |
| 00810112592764 | TriLeap Lower Extremity Anatomic Plating System | Synthes GmbH | 2024-02-23 |
| 00810112592566 | TriLeap Lower Etremity Anatomic Plating System | Synthes GmbH | 2024-02-23 |
| 00810112592573 | TriLeap Lower Extremity Anatomic Plating System | Synthes GmbH | 2024-02-23 |
| 00810112592580 | TriLeap Lower Extremity Anatomic Plating System | Synthes GmbH | 2024-02-23 |
| 00810112592740 | TriLeap Lower Extremity Anatomic Plating System | Synthes GmbH | 2024-02-23 |
| 00810112592757 | TriLeap Lower Extremity Anatomic Plating System | Synthes GmbH | 2024-02-23 |
| 00887868494758 | Vanguard® Instruments | Biomet Orthopedics, LLC | 2022-05-25 |
| 00810028391703 | Arsenal Ankle | Trilliant Surgical, LLC | 2022-05-02 |
| 00888118004260 | LEVEL ONE | KLS-Martin L.P. | 2018-09-26 |
| 00888118073136 | LEVEL ONE | KLS-Martin L.P. | 2018-09-26 |
| 00888118073167 | LEVEL ONE | KLS-Martin L.P. | 2018-09-26 |
| 00888118085450 | SONICWELD RX | KLS-Martin L.P. | 2018-09-26 |
| 04546540391391 | NA | Stryker Leibinger GmbH & Co. KG | 2016-12-08 |
| 04546540366788 | NA | Stryker Leibinger GmbH & Co. KG | 2016-10-19 |