The following data is part of a premarket notification filed by Corin Usa with the FDA for Trinity Non-occluded Titanium Plasma Sprayed (tps) Acetabular Shells.
| Device ID | K123705 |
| 510k Number | K123705 |
| Device Name: | TRINITY NON-OCCLUDED TITANIUM PLASMA SPRAYED (TPS) ACETABULAR SHELLS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | CORIN USA 5670 W. CYPRESS ST. SUITE C Tampa, FL 33607 |
| Contact | Diana L Martone |
| Correspondent | Diana L Martone CORIN USA 5670 W. CYPRESS ST. SUITE C Tampa, FL 33607 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-03 |
| Decision Date | 2013-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055343880968 | K123705 | 000 |
| 05055343880265 | K123705 | 000 |
| 05055343880609 | K123705 | 000 |
| 05055343880616 | K123705 | 000 |
| 05055343880623 | K123705 | 000 |
| 05055343880630 | K123705 | 000 |
| 05055343880647 | K123705 | 000 |
| 05055343880654 | K123705 | 000 |
| 05055343880661 | K123705 | 000 |
| 05055343880678 | K123705 | 000 |
| 05055343880685 | K123705 | 000 |
| 05055343880692 | K123705 | 000 |
| 05055343880708 | K123705 | 000 |
| 05055343880715 | K123705 | 000 |
| 05055343880951 | K123705 | 000 |
| 05055343880258 | K123705 | 000 |