FERNORAL HIP PROSTHESIS

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

CINTOR ORTHOPAEDIC DIV.

The following data is part of a premarket notification filed by Cintor Orthopaedic Div. with the FDA for Fernoral Hip Prosthesis.

Pre-market Notification Details

Device IDK803074
510k NumberK803074
Device Name:FERNORAL HIP PROSTHESIS
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant CINTOR ORTHOPAEDIC DIV. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-12-05
Decision Date1981-01-08

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