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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 K091263
Device Name ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER, MODEL 1.1 (4.3.0.35)
Applicant
Materialise NV
15 Technologielaan
Leuven,  BE 3001
Applicant Contact KARL VON BERGE
Correspondent
Materialise NV
15 Technologielaan
Leuven,  BE 3001
Correspondent Contact KARL VON BERGE
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
OOG  
Date Received04/30/2009
Decision Date 11/19/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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