The following data is part of a premarket notification filed by Corin U.s.a. with the FDA for Rotaglide + Modular Knee System With Fixed Meniscus.
| Device ID | K000232 |
| 510k Number | K000232 |
| Device Name: | ROTAGLIDE + MODULAR KNEE SYSTEM WITH FIXED MENISCUS |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-27 |
| Decision Date | 2000-02-25 |