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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K830121
Device Name INSALL/BURSTEIN FIBER METAL CONDYLAR/KNE
Applicant
Zimmer, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Zimmer, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number888.3560
Classification Product Code
JWH  
Date Received01/11/1983
Decision Date 04/26/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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