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 |
|---|---|---|---|
| 00196449017362 | A.L.P.S. mvX™ | Tyber Medical, LLC | 2026-06-04 |
| 00196449017584 | A.L.P.S. mvX™ | Tyber Medical, LLC | 2026-06-04 |
| 00196449017577 | A.L.P.S. mvX™ | Tyber Medical, LLC | 2026-06-04 |
| 00196449017560 | A.L.P.S. mvX™ | Tyber Medical, LLC | 2026-06-04 |
| 00196449017546 | A.L.P.S. mvX™ | Tyber Medical, LLC | 2026-06-04 |
| 00196449017539 | A.L.P.S. mvX™ | Tyber Medical, LLC | 2026-06-04 |
| 00196449017522 | A.L.P.S. mvX™ | Tyber Medical, LLC | 2026-06-04 |
| 00196449017515 | A.L.P.S. mvX™ | Tyber Medical, LLC | 2026-06-04 |
| 00196449017508 | A.L.P.S. mvX™ | Tyber Medical, LLC | 2026-06-04 |
| 00196449017492 | A.L.P.S. mvX™ | Tyber Medical, LLC | 2026-06-04 |
| 00196449017478 | A.L.P.S. mvX™ | Tyber Medical, LLC | 2026-06-04 |
| 00196449017461 | A.L.P.S. mvX™ | Tyber Medical, LLC | 2026-06-04 |
| 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 |
| 00196449017485 | A.L.P.S. mvX™ | Tyber Medical, LLC | 2026-06-04 |
| 00810030811671 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030811657 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00841732142343 | GENERIC Surgical Instruments | CTL Medical Corporation | 2025-03-31 |
| 00841732142350 | GENERIC Surgical Instruments | CTL Medical Corporation | 2025-03-31 |
| 00841732142367 | GENERIC Surgical Instruments | CTL Medical Corporation | 2025-03-31 |
| 00841732142374 | GENERIC Surgical Instruments | CTL Medical Corporation | 2025-03-31 |
| 00841732142381 | GENERIC Surgical Instruments | CTL Medical Corporation | 2025-03-31 |
| 00841732142398 | GENERIC Surgical Instruments | CTL Medical Corporation | 2025-03-31 |
| 00841732142404 | MONDRIAN ALIF | CTL Medical Corporation | 2025-03-31 |
| 00841732142411 | GENERIC Surgical Instruments | CTL Medical Corporation | 2025-03-31 |
| 00841732142480 | GENERIC Surgical Instruments | CTL Medical Corporation | 2025-03-31 |