PATELLAR PROSTHESIS

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

CUTTER LABORATORIES, INC.

The following data is part of a premarket notification filed by Cutter Laboratories, Inc. with the FDA for Patellar Prosthesis.

Pre-market Notification Details

Device IDK772225
510k NumberK772225
Device Name:PATELLAR PROSTHESIS
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant CUTTER LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1977-12-06
Decision Date1977-12-08

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