The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Gmrs Press Fit Stems With Purefix Ha.
| Device ID | K022403 |
| 510k Number | K022403 |
| Device Name: | GMRS PRESS FIT STEMS WITH PUREFIX HA |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Margaret F Crowe |
| Correspondent | Margaret F Crowe HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-23 |
| Decision Date | 2002-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327033748 | K022403 | 000 |
| 07613327033595 | K022403 | 000 |
| 07613327033588 | K022403 | 000 |
| 07613327033571 | K022403 | 000 |
| 07613327033564 | K022403 | 000 |
| 07613327033557 | K022403 | 000 |
| 07613327033540 | K022403 | 000 |
| 07613327033533 | K022403 | 000 |
| 07613327033526 | K022403 | 000 |
| 07613327033519 | K022403 | 000 |
| 07613327033502 | K022403 | 000 |
| 07613327033496 | K022403 | 000 |
| 07613327033601 | K022403 | 000 |
| 07613327033618 | K022403 | 000 |
| 07613327033731 | K022403 | 000 |
| 07613327033724 | K022403 | 000 |
| 07613327033717 | K022403 | 000 |
| 07613327033700 | K022403 | 000 |
| 07613327033694 | K022403 | 000 |
| 07613327033670 | K022403 | 000 |
| 07613327033663 | K022403 | 000 |
| 07613327033656 | K022403 | 000 |
| 07613327033649 | K022403 | 000 |
| 07613327033632 | K022403 | 000 |
| 07613327033625 | K022403 | 000 |
| 07613327033489 | K022403 | 000 |