The following data is part of a premarket notification filed by Sulzer Orthopedics, Inc. with the FDA for Inter-op Metasul Hooded And Protrusio Acetabular Inserts.
| Device ID | K001536 |
| 510k Number | K001536 |
| Device Name: | INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS |
| Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
| 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 | KWA |
| CFR Regulation Number | 888.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-17 |
| Decision Date | 2000-07-27 |