| Device Type ID | 4599 |
| Device Name | Spacer, Cement |
| Regulation Description | Hip Joint Metal/metal Semi-constrained, With A Cemented Acetabular Component, Prosthesis. |
| Regulation Medical Specialty | Orthopedic |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Joint And Fixation Devices Branch Two ¿ Hips/Wrists/Fingers (JFDB2) |
| Submission Type | 510(k) |
| CFR Regulation Number | 888.3320 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | LTO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4599 |
| Device | Spacer, Cement |
| Product Code | LTO |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Hip Joint Metal/metal Semi-constrained, With A Cemented Acetabular Component, Prosthesis. |
| CFR Regulation Number | 888.3320 [🔎] |
| Device Problems | |
|---|---|
Insufficient Information | 7 |
Adverse Event Without Identified Device Or Use Problem | 4 |
Loss Of Or Failure To Bond | 2 |
Delivered As Unsterile Product | 1 |
| Total Device Problems | 14 |