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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 K113829
Device Name ZIMMER PATIENT SPECIFIC INSTRUMENT SYSTEM ZIMMER PATIENT SPECIFIC INSTRUMENTS ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNE
Applicant
MATERIALISE N.V.
TECHNOLOGIELAAN 15
LEUVEN,  BE 3001
Applicant Contact Alexandra Razzhivina
Correspondent
MATERIALISE N.V.
TECHNOLOGIELAAN 15
LEUVEN,  BE 3001
Correspondent Contact Alexandra Razzhivina
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Codes
MBH   OOG  
Date Received12/27/2011
Decision Date 04/02/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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