KNEE PROSTHESIS

Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer

CINTOR ORTHOPAEDIC DIV.

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

Pre-market Notification Details

Device IDK810540
510k NumberK810540
Device Name:KNEE PROSTHESIS
ClassificationProsthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Applicant CINTOR ORTHOPAEDIC DIV. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeHRY  
CFR Regulation Number888.3530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-02-27
Decision Date1981-04-07

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