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 |
|---|---|---|---|
| B7685671280 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2025-12-12 |
| B7685671240 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2025-09-24 |
| B7685673120 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2024-10-31 |
| B7685672060 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2024-10-31 |
| B7685672100 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2024-06-05 |
| B7685671950 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2024-05-31 |
| B7685673100 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2024-04-17 |
| B7685673080 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2023-10-20 |
| B7685673060 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2023-10-20 |
| B7685672080 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2023-10-20 |
| B7685672040 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2023-10-20 |
| B7685671320 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2023-10-20 |
| B7685671300 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2023-10-20 |
| B7682442010 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2023-06-09 |
| B7682442990 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2023-06-09 |
| B7682442160 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2023-06-09 |
| B7682442050 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2023-06-09 |
| B7682442910 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2023-05-26 |
| B7682443150 | Buxton Biomedical | BUXTON BIOMEDICAL, INC. | 2023-05-19 |
| B7682442250 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2023-04-12 |
| B7682442000 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2023-03-10 |
| B7682442100 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2023-02-02 |
| B7685671100 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2022-12-22 |
| B7685671120 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2022-12-22 |
| B7685671150 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2022-12-22 |
| B7685671080 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2022-12-22 |
| B7685671060 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2022-12-22 |
| B7685671040 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2022-12-22 |
| B7685671030 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2022-12-22 |
| B7685671020 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2022-12-22 |