| Device Type ID | 5706 |
| Device Name | Prosthesis, Ptfe/carbon-fiber |
| Regulation Description | Polytetrafluoroethylene With Carbon Fibers Composite Implant Material. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch One - Implants And Tools (PRSB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.3500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KDA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5706 |
| Device | Prosthesis, Ptfe/carbon-fiber |
| Product Code | KDA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Polytetrafluoroethylene With Carbon Fibers Composite Implant Material. |
| CFR Regulation Number | 878.3500 [🔎] |
| Device Problems | |
|---|---|
Insufficient Information | 1 |
| Total Device Problems | 1 |