The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Trident Constrained Acetabular Insert.
| Device ID | K061654 |
| 510k Number | K061654 |
| Device Name: | TRIDENT CONSTRAINED ACETABULAR INSERT |
| Classification | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer |
| Applicant | HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | Joseph Viola |
| Correspondent | Joseph Viola HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | KWZ |
| CFR Regulation Number | 888.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-13 |
| Decision Date | 2006-07-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327025606 | K061654 | 000 |
| 07613327025453 | K061654 | 000 |
| 07613327025460 | K061654 | 000 |
| 07613327025477 | K061654 | 000 |
| 07613327025484 | K061654 | 000 |
| 07613327025491 | K061654 | 000 |
| 07613327025507 | K061654 | 000 |
| 07613327025514 | K061654 | 000 |
| 07613327025538 | K061654 | 000 |
| 07613327025545 | K061654 | 000 |
| 07613327025552 | K061654 | 000 |
| 07613327025569 | K061654 | 000 |
| 07613327025576 | K061654 | 000 |
| 07613327025583 | K061654 | 000 |
| 07613327025590 | K061654 | 000 |
| 07613327025446 | K061654 | 000 |