The following data is part of a premarket notification filed by Corin Usa Limited with the FDA for Unity Total Knee System.
| Device ID | K170808 |
| 510k Number | K170808 |
| Device Name: | Unity Total Knee System |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Corin USA Limited 5670 W Cypress Street, Suite C Tampa, FL 33607 |
| Contact | Rachel King |
| Correspondent | Rachel King Corin USA Limited 5670 W Cypress Street, Suite C Tampa, FL 33607 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-17 |
| Decision Date | 2017-07-13 |
| Summary: | summary |