Product code HWM
- Device name
- Osteotome
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4800
- Review panel
- SU
- 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#
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810111227360 | Osteotome | Treace Medical Concepts, Inc. | 2026-08-25 |
| 00190776425807 | Millennium | Avalign Technologies, Inc. | 2026-08-17 |
| 10705034579887 | N/A | Medos International Sàrl | 2026-08-14 |
| 10705034579894 | N/A | Medos International Sàrl | 2026-08-14 |
| 00190776424459 | Millennium | Avalign Technologies, Inc. | 2026-08-07 |
| 00190776424466 | Millennium | Avalign Technologies, Inc. | 2026-08-07 |
| 00190776424473 | Millennium | Avalign Technologies, Inc. | 2026-08-07 |
| 00190776422738 | Millennium | Avalign Technologies, Inc. | 2026-08-03 |
| 07640221373663 | SCALA | SpineArt SA | 2026-07-24 |
| 07640221373670 | SCALA | SpineArt SA | 2026-07-24 |
| 00190776421861 | Millennium | Avalign Technologies, Inc. | 2026-07-23 |
| 00190776400422 | Millennium | Avalign Technologies, Inc. | 2026-07-17 |
| 00190776400439 | Millennium | Avalign Technologies, Inc. | 2026-07-17 |
| B756SBLDFLAT17010 | Shukla Blade S9BLADE | Shukla Medical | 2026-07-09 |
| B756SBLDFLAT17020 | Shukla Blade S9BLADE | Shukla Medical | 2026-07-09 |
| 00810212930084 | SURGIPROS | Surgipros, LLC | 2026-06-01 |
| 00810212930077 | SURGIPROS | Surgipros, LLC | 2026-06-01 |
| 00810212930060 | SURGIPROS | Surgipros, LLC | 2026-06-01 |
| 00810212930053 | SURGIPROS | Surgipros, LLC | 2026-06-01 |
| 00810212930046 | SURGIPROS | Surgipros, LLC | 2026-06-01 |
| 00810212930039 | SURGIPROS | Surgipros, LLC | 2026-06-01 |
| 00810212930022 | SURGIPROS | Surgipros, LLC | 2026-06-01 |
| 00810212930015 | SURGIPROS | Surgipros, LLC | 2026-06-01 |
| 00810212930008 | SURGIPROS | Surgipros, LLC | 2026-06-01 |
| 00810143907315 | SURGIPROS | Surgipros, LLC | 2026-06-01 |
| 00810143907308 | SURGIPROS | Surgipros, LLC | 2026-06-01 |
| 00810143907278 | SURGIPROS | Surgipros, LLC | 2026-06-01 |
| 00810143907261 | SURGIPROS | Surgipros, LLC | 2026-06-01 |
| 00810143904673 | SURGIPROS | Surgipros, LLC | 2026-06-01 |
| 00810143904666 | SURGIPROS | Surgipros, LLC | 2026-06-01 |