The following data is part of a premarket notification filed by Sulzer Orthopedics, Inc. with the FDA for Inter-op Acetabular System - Durasul Acetabular Insert.
| Device ID | K983509 |
| 510k Number | K983509 |
| Device Name: | INTER-OP ACETABULAR SYSTEM - DURASUL ACETABULAR INSERT |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Contact | Shavawn E Parduhn |
| Correspondent | Shavawn E Parduhn SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-07 |
| Decision Date | 1999-02-03 |
| Summary: | summary |