The following data is part of a premarket notification filed by Centerpulse Orthopedics, Inc. with the FDA for Epsilon Metasul 32mm Acetabular Inserts, Standard And Hooded.
| Device ID | K033634 |
| 510k Number | K033634 |
| Device Name: | EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED |
| Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
| Applicant | CENTERPULSE ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Contact | Audrey Swearingen |
| Correspondent | Audrey Swearingen CENTERPULSE 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 | 2003-11-19 |
| Decision Date | 2004-09-15 |
| Summary: | summary |