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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 K133162
Device Name ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLA
Applicant
Materialise N.V
Technologielaan 15
Leuven,  BE 3001
Applicant Contact OLIVER CLEMENS
Correspondent
Materialise N.V
Technologielaan 15
Leuven,  BE 3001
Correspondent Contact OLIVER CLEMENS
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Codes
MBH   OIY   OOG  
Date Received10/17/2013
Decision Date 02/25/2014
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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