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 |
|---|---|---|---|
| 00810143904673 | SURGIPROS | Surgipros, LLC | 2026-06-01 |
| 00810212930114 | SURGIPROS | Surgipros, LLC | 2026-06-01 |
| 00810212930107 | SURGIPROS | Surgipros, LLC | 2026-06-01 |
| 00810212930091 | SURGIPROS | Surgipros, LLC | 2026-06-01 |
| 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 |
| 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 |
| 00810143904666 | SURGIPROS | Surgipros, LLC | 2026-06-01 |
| 00810212930039 | SURGIPROS | Surgipros, LLC | 2026-06-01 |
| 09348811110442 | INKA | The Trustee for KAISER FAMILY TRUST | 2026-03-18 |
| 09348811111289 | INKA | The Trustee for KAISER FAMILY TRUST | 2026-03-18 |
| 09348811099624 | INKA | The Trustee for KAISER FAMILY TRUST | 2026-03-18 |
| 10381780193098 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-03 |
| 10381780193838 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-03 |
| 10381780193845 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-03 |
| 10381780193050 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-02 |
| 10381780051497 | METIS® | NEWDEAL | 2017-05-26 |
| 10381780199403 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-05-16 |
| 10381780199410 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-05-16 |
| 10381780199427 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-05-16 |
| 10381780199434 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-05-16 |