The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Acetabular Plates.
| Device ID | K002941 |
| 510k Number | K002941 |
| Device Name: | ACETABULAR PLATES |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented |
| Applicant | ENCORE ORTHOPEDICS, INC. 9800 METRIC BLVD. Austin, TX 78758 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb ENCORE ORTHOPEDICS, INC. 9800 METRIC BLVD. Austin, TX 78758 |
| Product Code | LWJ |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-21 |
| Decision Date | 2000-12-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912087131 | K002941 | 000 |
| 00888912086974 | K002941 | 000 |
| 00888912086998 | K002941 | 000 |
| 00888912087018 | K002941 | 000 |
| 00888912087032 | K002941 | 000 |
| 00888912087056 | K002941 | 000 |
| 00888912087070 | K002941 | 000 |
| 00888912087094 | K002941 | 000 |
| 00888912087117 | K002941 | 000 |
| 00888912086950 | K002941 | 000 |