The following data is part of a premarket notification filed by Corin U.s.a. with the FDA for Zyranox Zirconia Ceramic Femoral Heads.
| Device ID | K992235 |
| 510k Number | K992235 |
| Device Name: | ZYRANOX ZIRCONIA CERAMIC FEMORAL HEADS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | CORIN U.S.A. 10500 UNIVERSITY CENTER DR., SUITE 190 Tampa, FL 33612 |
| Contact | Craig Corrance |
| Correspondent | Craig Corrance CORIN U.S.A. 10500 UNIVERSITY CENTER DR., SUITE 190 Tampa, FL 33612 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-02 |
| Decision Date | 1999-11-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055196928879 | K992235 | 000 |
| 05055196928749 | K992235 | 000 |
| 05055196928756 | K992235 | 000 |
| 05055196928763 | K992235 | 000 |
| 05055196928770 | K992235 | 000 |
| 05055196928787 | K992235 | 000 |
| 05055196928824 | K992235 | 000 |
| 05055196928831 | K992235 | 000 |
| 05055196928848 | K992235 | 000 |
| 05055196928855 | K992235 | 000 |
| 05055196928862 | K992235 | 000 |
| 05055196928732 | K992235 | 000 |