| Device Type ID | 4697 |
| Device Name | Mesh, Surgical, Acetabular, Hip, Prosthesis |
| 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 | JDJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4697 |
| Device | Mesh, Surgical, Acetabular, Hip, Prosthesis |
| Product Code | JDJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Mesh. |
| CFR Regulation Number | 878.3300 [🔎] |
| Device Problems | |
|---|---|
Insufficient Information | 20 |
Adverse Event Without Identified Device Or Use Problem | 11 |
Appropriate Term/Code Not Available | 11 |
Device Dislodged Or Dislocated | 2 |
Failure To Adhere Or Bond | 1 |
Fracture | 1 |
Migration Or Expulsion Of Device | 1 |
Difficult To Remove | 1 |
Break | 1 |
| Total Device Problems | 49 |