| Device Type ID | 5573 |
| Device Name | Chisel, Surgical, 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 | FZO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5573 |
| Device | Chisel, Surgical, Manual |
| Product Code | FZO |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Surgical Instrument For General Use. |
| CFR Regulation Number | 878.4800 [🔎] |
| Device Problems | |
|---|---|
Break | 84 |
Material Deformation | 8 |
Material Fragmentation | 7 |
Fracture | 5 |
Dull, Blunt | 3 |
Material Twisted / Bent | 2 |
Failure To Cut | 2 |
Appropriate Term/Code Not Available | 1 |
Material Split, Cut Or Torn | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Device Operates Differently Than Expected | 1 |
Corroded | 1 |
Crack | 1 |
Insufficient Information | 1 |
Mechanical Jam | 1 |
Difficult To Fold Or Unfold | 1 |
| Total Device Problems | 120 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Synthes (USA) Products LLC | II | Jul-16-2015 |