The following data is part of a premarket notification filed by Corin Usa Limited with the FDA for Unity Total Knee System.
| Device ID | K183533 |
| 510k Number | K183533 |
| Device Name: | Unity Total Knee System |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Corin USA Limited 12750 Citrus Park Lane, Suite 120 Tampa, FL 33625 |
| Contact | Lucinda Gerber |
| Correspondent | Lucinda Gerber Corin USA Limited 12750 Citrus Park Lane, Suite 120 Tampa, FL 33625 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-19 |
| Decision Date | 2019-06-04 |