The following data is part of a premarket notification filed by Corin Usa Limited with the FDA for Corin Bipolar-i.
| Device ID | K183114 |
| 510k Number | K183114 |
| Device Name: | Corin BiPolar-i |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | Corin USA Limited 12750 Citrus Park Lane Tampa, FL 33625 |
| Contact | Homer Trieu |
| Correspondent | Homer Trieu Corin USA Limited 12750 Citrus Park Lane Tampa, FL 33625 |
| Product Code | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-09 |
| Decision Date | 2019-06-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05056139234576 | K183114 | 000 |
| 05056139234422 | K183114 | 000 |
| 05056139234415 | K183114 | 000 |
| 05056139234408 | K183114 | 000 |
| 05056139234392 | K183114 | 000 |
| 05056139234385 | K183114 | 000 |
| 05056139234378 | K183114 | 000 |
| 05056139234361 | K183114 | 000 |
| 05056139234354 | K183114 | 000 |
| 05056139234330 | K183114 | 000 |
| 05056139234323 | K183114 | 000 |
| 05056139234286 | K183114 | 000 |
| 05055343860786 | K183114 | 000 |
| 05056139234439 | K183114 | 000 |
| 05056139234446 | K183114 | 000 |
| 05056139234569 | K183114 | 000 |
| 05056139234552 | K183114 | 000 |
| 05056139234545 | K183114 | 000 |
| 05056139234538 | K183114 | 000 |
| 05056139234521 | K183114 | 000 |
| 05056139234514 | K183114 | 000 |
| 05056139234507 | K183114 | 000 |
| 05056139234491 | K183114 | 000 |
| 05056139234484 | K183114 | 000 |
| 05056139234477 | K183114 | 000 |
| 05056139234460 | K183114 | 000 |
| 05056139234453 | K183114 | 000 |
| 05056139234309 | K183114 | 000 |