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 |
|---|---|---|---|
| 00192896123946 | Micro Osteotome | SONTEC INSTRUMENTS, INC. | 2026-10-27 |
| 00190776435516 | Millennium | Avalign Technologies, Inc. | 2026-10-20 |
| 00190776435523 | Millennium | Avalign Technologies, Inc. | 2026-10-20 |
| 00190776435592 | Millennium | Avalign Technologies, Inc. | 2026-10-20 |
| 00190776437671 | Millenium | Avalign Technologies, Inc. | 2026-10-20 |
| 00190776437732 | Millenium | Avalign Technologies, Inc. | 2026-10-20 |
| 00190776437817 | Millenium | Avalign Technologies, Inc. | 2026-10-20 |
| 00190776435127 | Millennium | Avalign Technologies, Inc. | 2026-10-15 |
| 00190776435134 | Millennium | Avalign Technologies, Inc. | 2026-10-15 |
| 00840277133915 | Innomed, Inc. | INNOMED, INC. | 2026-10-09 |
| 00190776434007 | Millennium | Avalign Technologies, Inc. | 2026-10-08 |
| 00190776436261 | Millennium | Avalign Technologies, Inc. | 2026-10-08 |
| G141646640020 | Carnegie Surgical LLC | Carnegie Surgical LLC | 2026-10-07 |
| G141549966080 | Carnegie Surgical LLC | Carnegie Surgical LLC | 2026-10-07 |
| G141548807060 | Carnegie Surgical LLC | Carnegie Surgical LLC | 2026-10-07 |
| G141548807040 | Carnegie Surgical LLC | Carnegie Surgical LLC | 2026-10-07 |
| B7687715080 | Buxton Biomedical, Inc | BUXTON BIOMEDICAL, INC. | 2026-10-06 |
| 00190776432935 | Millennium | Avalign Technologies, Inc. | 2026-09-30 |
| 00840329838676 | BLACK & BLACK SURGICAL, INC. | BLACK & BLACK SURGICAL, INC. | 2026-09-30 |
| 00840329838683 | BLACK & BLACK SURGICAL, INC. | BLACK & BLACK SURGICAL, INC. | 2026-09-30 |
| G14164746930 | Carnegie Surgical LLC | Carnegie Surgical LLC | 2026-09-30 |
| G141647481020 | Carnegie Surgical LLC | Carnegie Surgical LLC | 2026-09-30 |
| 00190776432812 | Millennium | Avalign Technologies, Inc. | 2026-09-29 |
| 00190776432713 | Millennium | Avalign Technologies, Inc. | 2026-09-28 |
| 00190776432720 | Millennium | Avalign Technologies, Inc. | 2026-09-28 |
| 00190776432737 | Millennium | Avalign Technologies, Inc. | 2026-09-28 |
| B7682442010 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2023-06-09 |
| B7682442050 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2023-06-09 |
| B7682442000 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2023-03-10 |
| B7682442100 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2023-02-02 |