The following data is part of a premarket notification filed by Corin Orthopedic Products with the FDA for Nuffield Total Knee Uhmwpe Tibia (one Piece) Modification.
| Device ID | K934166 |
| 510k Number | K934166 |
| Device Name: | NUFFIELD TOTAL KNEE UHMWPE TIBIA (ONE PIECE) MODIFICATION |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | CORIN ORTHOPEDIC PRODUCTS 10500 UNIVERSITY CENTER DR. SUITE 130 Tampa, FL 33612 |
| Contact | Jack Thomas |
| Correspondent | Jack Thomas CORIN ORTHOPEDIC PRODUCTS 10500 UNIVERSITY CENTER DR. SUITE 130 Tampa, FL 33612 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-27 |
| Decision Date | 1994-09-07 |