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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| 00888867574557 | Arthrex® | ARTHREX, INC. | 2026-09-18 |
| 00888867574540 | Arthrex® | ARTHREX, INC. | 2026-09-18 |
| 00190776400644 | Millennium | Avalign Technologies, Inc. | 2026-07-19 |
| 00190776402075 | Millennium | Avalign Technologies, Inc. | 2026-07-19 |
| 00190776402082 | Millennium | Avalign Technologies, Inc. | 2026-07-19 |
| 00190776400576 | Millennium | Avalign Technologies, Inc. | 2026-07-19 |
| 00190776400552 | Millennium | Avalign Technologies, Inc. | 2026-07-19 |
| 00190776400293 | Millennium | Avalign Technologies, Inc. | 2026-07-17 |
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