| Device Type ID | 5658 |
| Device Name | Driver, Surgical, Pin |
| Regulation Description | Surgical Instrument Motors And Accessories/attachments. |
| 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 One - Light Based/Laser (GSDB1) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4820 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | GFC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5658 |
| Device | Driver, Surgical, Pin |
| Product Code | GFC |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Surgical Instrument Motors And Accessories/attachments. |
| CFR Regulation Number | 878.4820 [🔎] |
| Device Problems | |
|---|---|
Detachment Of Device Component | 3 |
Device Operates Differently Than Expected | 2 |
Device Inoperable | 1 |
Vibration | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Material Separation | 1 |
Break | 1 |
Detachment Of Device Or Device Component | 1 |
Insufficient Information | 1 |
| Total Device Problems | 12 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Zimmer, Inc. | II | Sep-30-2014 |