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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 K110533
Device Name STRYKER PATIENT SPECIFIC CUTTING GUIDE
Applicant
Stryker Corp.
325 Corporate Dr.
Malwah,  NJ  07430
Applicant Contact KAREN ARIEMMA
Correspondent
Stryker Corp.
325 Corporate Dr.
Malwah,  NJ  07430
Correspondent Contact KAREN ARIEMMA
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Codes
JWH   OOG  
Date Received02/24/2011
Decision Date 05/19/2011
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
Recalls CDRH Recalls
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