The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Metal Backed Acetabular Component.
| Device ID | K950542 |
| 510k Number | K950542 |
| Device Name: | METAL BACKED ACETABULAR COMPONENT |
| Classification | Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) |
| Applicant | ENCORE ORTHOPEDICS, INC. 8920 BUSINESS PARK DR. SUTIE 380 Austin, TX 78759 |
| Contact | J. D Webb |
| Correspondent | J. D Webb ENCORE ORTHOPEDICS, INC. 8920 BUSINESS PARK DR. SUTIE 380 Austin, TX 78759 |
| Product Code | JDL |
| CFR Regulation Number | 888.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-07 |
| Decision Date | 1995-05-25 |