| Device Type ID | 5663 |
| Device Name | Osteotome, Manual |
| Regulation Description | Manual Surgical Instrument For General Use. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch Two - Surgical (GSDB2) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4800 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | GFI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5663 |
| Device | Osteotome, Manual |
| Product Code | GFI |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Surgical Instrument For General Use. |
| CFR Regulation Number | 878.4800 [🔎] |
| Device Problems | |
|---|---|
Break | 7 |
Difficult To Remove | 7 |
Use Of Device Problem | 4 |
Material Separation | 4 |
No Audible Alarm | 3 |
Bent | 2 |
Material Twisted / Bent | 1 |
Appropriate Term/Code Not Available | 1 |
Device Alarm System | 1 |
| Total Device Problems | 30 |