The following data is part of a premarket notification filed by Corin Usa with the FDA for Corin Biolox Delta Femoral Heads.
| Device ID | K103120 |
| 510k Number | K103120 |
| Device Name: | CORIN BIOLOX DELTA FEMORAL HEADS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | CORIN USA 10500 UNIVERSITY CENTER DRIVE SUITE 190 Tampa, FL 33612 |
| Contact | Lucinda Gerber |
| Correspondent | Lucinda Gerber CORIN USA 10500 UNIVERSITY CENTER DRIVE 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 | 2010-10-22 |
| Decision Date | 2011-02-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055196964365 | K103120 | 000 |
| 05055196964358 | K103120 | 000 |
| 05055196964341 | K103120 | 000 |
| 05055196964334 | K103120 | 000 |
| 05055196964327 | K103120 | 000 |
| 05055196964310 | K103120 | 000 |