The following data is part of a premarket notification filed by Sulzer Orthopedics, Inc. with the FDA for Ascendent Acetabular System.
| Device ID | K022985 |
| 510k Number | K022985 |
| Device Name: | ASCENDENT ACETABULAR SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Contact | Frances E Harrison |
| Correspondent | Frances E Harrison SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Product Code | LZO |
| Subsequent Product Code | JDJ |
| Subsequent Product Code | KWA |
| Subsequent Product Code | LWJ |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-09 |
| Decision Date | 2002-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024183612 | K022985 | 000 |
| 00889024181120 | K022985 | 000 |
| 00889024180505 | K022985 | 000 |
| 00889024180468 | K022985 | 000 |
| 00889024180451 | K022985 | 000 |
| 00889024180444 | K022985 | 000 |
| 00889024180437 | K022985 | 000 |
| 00889024180420 | K022985 | 000 |
| 00889024180413 | K022985 | 000 |
| 00889024180406 | K022985 | 000 |
| 00889024180390 | K022985 | 000 |
| 00889024180383 | K022985 | 000 |
| 00889024180376 | K022985 | 000 |
| 00889024181458 | K022985 | 000 |
| 00889024181465 | K022985 | 000 |
| 00889024181502 | K022985 | 000 |
| 00889024183605 | K022985 | 000 |
| 00889024183599 | K022985 | 000 |
| 00889024183582 | K022985 | 000 |
| 00889024183575 | K022985 | 000 |
| 00889024183568 | K022985 | 000 |
| 00889024183551 | K022985 | 000 |
| 00889024183544 | K022985 | 000 |
| 00889024183537 | K022985 | 000 |
| 00889024183520 | K022985 | 000 |
| 00889024183391 | K022985 | 000 |
| 00889024183384 | K022985 | 000 |
| 00889024183377 | K022985 | 000 |
| 00889024180369 | K022985 | 000 |