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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 K122053
Device Name SHAPEMATCH CUTTING GUIDE
Applicant
STRYKER CORP.
1600 HARBOR BAY DRIVE
SUITE 200
ALAMEDA,  CA  94502
Applicant Contact TAMMY WHARTON
Correspondent
STRYKER CORP.
1600 HARBOR BAY DRIVE
SUITE 200
ALAMEDA,  CA  94502
Correspondent Contact TAMMY WHARTON
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Codes
JWH   OOG  
Date Received07/13/2012
Decision Date 10/24/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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