The following data is part of a premarket notification filed by Sulzer Orthopedics, Inc. with the FDA for Inter-op Durasul Acetabular Inserts (4mm).
| Device ID | K002575 |
| 510k Number | K002575 |
| Device Name: | INTER-OP DURASUL ACETABULAR INSERTS (4MM) |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented |
| Applicant | SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Contact | Mitchell A Dhority |
| Correspondent | Mitchell A Dhority SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Product Code | LWJ |
| Subsequent Product Code | JDI |
| Subsequent Product Code | LPH |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-18 |
| Decision Date | 2000-11-15 |