The following data is part of a premarket notification filed by Cintor Orthopaedic Div. with the FDA for Fernoral Hip Prosthesis.
Device ID | K803074 |
510k Number | K803074 |
Device Name: | FERNORAL HIP PROSTHESIS |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
Applicant | CINTOR ORTHOPAEDIC DIV. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JDI |
CFR Regulation Number | 888.3350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-12-05 |
Decision Date | 1981-01-08 |