The following data is part of a premarket notification filed by Corin U.s.a. with the FDA for The Posterior Stabilised Nuffield Total Knee System.
| Device ID | K973595 |
| 510k Number | K973595 |
| Device Name: | THE POSTERIOR STABILISED NUFFIELD TOTAL KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | CORIN U.S.A. 10500 UNIVERSITY CENTER DR., SUITE 190 Tampa, FL 33612 |
| Contact | Craig Corrance |
| Correspondent | Craig Corrance CORIN U.S.A. 10500 UNIVERSITY CENTER DR., SUITE 190 Tampa, FL 33612 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-22 |
| Decision Date | 1997-12-19 |
| Summary: | summary |