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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, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
510(k) Number K093533
Device Name ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0
Applicant
MATERIALISE N.V.
15 TECHNOLOGIELAAN
LEUVEN,  BE 3001
Applicant Contact KARL VOM BERGE
Correspondent
MATERIALISE N.V.
15 TECHNOLOGIELAAN
LEUVEN,  BE 3001
Correspondent Contact KARL VOM BERGE
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Code
JWH  
Date Received11/16/2009
Decision Date 02/17/2010
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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