The following data is part of a premarket notification filed by Cintor Orthopaedic Div. with the FDA for Knee Prosthesis.
Device ID | K810540 |
510k Number | K810540 |
Device Name: | KNEE PROSTHESIS |
Classification | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer |
Applicant | CINTOR ORTHOPAEDIC DIV. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HRY |
CFR Regulation Number | 888.3530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-02-27 |
Decision Date | 1981-04-07 |