The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Series Ii Constrained Acetabular Liners.
| Device ID | K063552 |
| 510k Number | K063552 |
| Device Name: | SERIES II 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 | 2006-11-24 |
| Decision Date | 2007-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327460995 | K063552 | 000 |
| 07613327138337 | K063552 | 000 |
| 07613327138344 | K063552 | 000 |
| 07613327138351 | K063552 | 000 |
| 07613327138368 | K063552 | 000 |
| 07613327138375 | K063552 | 000 |
| 07613327138382 | K063552 | 000 |
| 07613327138399 | K063552 | 000 |
| 07613327138405 | K063552 | 000 |
| 07613327138429 | K063552 | 000 |
| 07613327138436 | K063552 | 000 |
| 07613327138443 | K063552 | 000 |
| 07613327138504 | K063552 | 000 |
| 07613327138559 | K063552 | 000 |
| 07613327138290 | K063552 | 000 |