The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Pca Constrained Acetabular Liners.
| Device ID | K063445 |
| 510k Number | K063445 |
| Device Name: | PCA CONSTRAINED ACETABULAR LINERS |
| Classification | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer |
| Applicant | HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | Francisco Haro |
| Correspondent | Francisco Haro HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | KWZ |
| CFR Regulation Number | 888.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-15 |
| Decision Date | 2007-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327455809 | K063445 | 000 |
| 07613327138641 | K063445 | 000 |
| 07613327138627 | K063445 | 000 |
| 07613327138610 | K063445 | 000 |
| 07613327138603 | K063445 | 000 |
| 07613327138597 | K063445 | 000 |
| 07613327138573 | K063445 | 000 |
| 07613327138566 | K063445 | 000 |
| 07613327138542 | K063445 | 000 |
| 07613327138528 | K063445 | 000 |
| 07613327138320 | K063445 | 000 |
| 07613327138252 | K063445 | 000 |
| 07613327138658 | K063445 | 000 |
| 07613327138665 | K063445 | 000 |
| 07613327138870 | K063445 | 000 |
| 07613327138795 | K063445 | 000 |
| 07613327138788 | K063445 | 000 |
| 07613327138757 | K063445 | 000 |
| 07613327138733 | K063445 | 000 |
| 07613327138726 | K063445 | 000 |
| 07613327138719 | K063445 | 000 |
| 07613327138702 | K063445 | 000 |
| 07613327138696 | K063445 | 000 |
| 07613327138689 | K063445 | 000 |
| 07613327138672 | K063445 | 000 |
| 07613327139037 | K063445 | 000 |