| Device Type ID | 5678 |
| Device Name | Elevator |
| 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 One - Light Based/Laser (GSDB1) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4800 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | HTE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5678 |
| Device | Elevator |
| Product Code | HTE |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Surgical Instrument For General Use. |
| CFR Regulation Number | 878.4800 [🔎] |
| Device Problems | |
|---|---|
Break | 21 |
Device Contamination With Chemical Or Other Material | 3 |
Material Fragmentation | 3 |
Crack | 2 |
Material Discolored | 2 |
Device Operates Differently Than Expected | 2 |
Material Twisted / Bent | 1 |
Contamination / Decontamination Problem | 1 |
Material Deformation | 1 |
Unintended Movement | 1 |
| Total Device Problems | 37 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | SpineFrontier, Inc. | II | Jan-16-2014 |