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 |
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| 07630008439866 | APTUS | Medartis AG | 2026-07-16 |
| 00190776395438 | Millennium | Avalign Technologies, Inc. | 2026-07-13 |
| 00190446932406 | Arsenal Foot | Trilliant Surgical, LLC | 2026-06-25 |
| 00190446948216 | Arsenal Foot | Trilliant Surgical, LLC | 2026-06-25 |
| 00190446948483 | Arsenal Foot | Trilliant Surgical, LLC | 2026-06-25 |
| 09353903030218 | Griplasty System | FIELD ORTHOPAEDICS PTY LTD | 2026-06-24 |
| 00889795154521 | Spider Monkey Bone Transport System | Paragon 28, Inc. | 2026-06-10 |
| 08800089483457 | Summa Orthopaedics System Surgical Instrument | Jeil Medical Corporation | 2026-06-10 |
| 08800089483433 | Drill bit | Jeil Medical Corporation | 2026-06-10 |
| 00889795154606 | Spider Monkey Bone Transport System | Paragon 28, Inc. | 2026-06-10 |
| 00889795154514 | Spider Monkey Bone Transport System | Paragon 28, Inc. | 2026-06-10 |
| 00889795154507 | Spider Monkey Bone Transport System | Paragon 28, Inc. | 2026-06-10 |
| 04052536176700 | neon3 | Ulrich GmbH & Co. KG | 2026-06-08 |
| 04052536176717 | neon3 | Ulrich GmbH & Co. KG | 2026-06-08 |
| 00196449017447 | A.L.P.S. mvX™ | Tyber Medical, LLC | 2026-06-04 |
| 00196449017430 | A.L.P.S. mvX™ | Tyber Medical, LLC | 2026-06-04 |
| 00196449017423 | A.L.P.S. mvX™ | Tyber Medical, LLC | 2026-06-04 |
| 00196449017416 | A.L.P.S. mvX™ | Tyber Medical, LLC | 2026-06-04 |
| 00196449017409 | A.L.P.S. mvX™ | Tyber Medical, LLC | 2026-06-04 |
| 00196449017355 | A.L.P.S. mvX™ | Tyber Medical, LLC | 2026-06-04 |
| 00196449017362 | A.L.P.S. mvX™ | Tyber Medical, LLC | 2026-06-04 |
| 08809885799809 | QUASAR Standalone ACIF System | GS Medical Co., Ltd. | 2025-03-17 |
| 10855068008560 | Cannulated Step Drill, Small Implant | CURVAFIX, INC. | 2022-12-05 |
| 10855068008201 | Step Drill | CURVAFIX, INC. | 2021-08-11 |
| 00815362021439 | Slimplicity Anterior Cervical Plate System | PRECISION SPINE, INC. | 2019-03-29 |
| 00815362021408 | Slimplicity Anterior Cervical Plate System | PRECISION SPINE, INC. | 2019-03-29 |
| 00815362021415 | Slimplicity Anterior Cervical Plate System | PRECISION SPINE, INC. | 2019-03-29 |
| 00815362021422 | Slimplicity Anterior Cervical Plate System | PRECISION SPINE, INC. | 2019-03-29 |
| 10705034714592 | NA | Synthes GmbH | 2016-12-31 |