| Device Type ID | 5682 |
| Device Name | Osteotome |
| 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 | HWM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5682 |
| Device | Osteotome |
| Product Code | HWM |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Surgical Instrument For General Use. |
| CFR Regulation Number | 878.4800 [🔎] |
| Device Problems | |
|---|---|
Break | 64 |
Dull, Blunt | 15 |
Material Deformation | 8 |
Material Twisted / Bent | 6 |
Appropriate Term/Code Not Available | 5 |
Material Fragmentation | 5 |
Naturally Worn | 5 |
Fracture | 4 |
Bent | 3 |
Device Operates Differently Than Expected | 3 |
Insufficient Information | 2 |
Detachment Of Device Or Device Component | 2 |
Scratched Material | 2 |
Detachment Of Device Component | 2 |
Separation Problem | 1 |
Device Reprocessing Problem | 1 |
Migration Or Expulsion Of Device | 1 |
Pitted | 1 |
Disassembly | 1 |
Component Missing | 1 |
| Total Device Problems | 132 |