| Device Type ID | 4698 |
| Device Name | Prosthesis, Hip, Cement Restrictor |
| Regulation Description | Surgical Mesh. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | Orthopedic |
| 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) |
| CFR Regulation Number | 878.3300 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | JDK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4698 |
| Device | Prosthesis, Hip, Cement Restrictor |
| Product Code | JDK |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Mesh. |
| CFR Regulation Number | 878.3300 [🔎] |
| Device Problems | |
|---|---|
Break | 3 |
Insufficient Information | 3 |
Loose Or Intermittent Connection | 1 |
Ring | 1 |
Loss Of Or Failure To Bond | 1 |
Device Dislodged Or Dislocated | 1 |
| Total Device Problems | 10 |