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 |