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 |