INSALL/BURSTEIN FIBER METAL CONDYLAR/KNE

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

ZIMMER, INC.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Insall/burstein Fiber Metal Condylar/kne.

Pre-market Notification Details

Device IDK830121
510k NumberK830121
Device Name:INSALL/BURSTEIN FIBER METAL CONDYLAR/KNE
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant ZIMMER, 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 Received1983-01-11
Decision Date1983-04-26

NIH GUDID Devices

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