The following data is part of a premarket notification filed by Centerpulse Orthopedics, Inc. with the FDA for Epsilon Durasul Constrained Acetabular Liner.
| Device ID | K030923 |
| 510k Number | K030923 |
| Device Name: | EPSILON DURASUL CONSTRAINED ACETABULAR LINER |
| Classification | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer |
| Applicant | CENTERPULSE ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Contact | Robert M Wolfarth |
| Correspondent | Robert M Wolfarth CENTERPULSE ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Product Code | KWZ |
| CFR Regulation Number | 888.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-24 |
| Decision Date | 2003-10-03 |
| Summary: | summary |