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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plate, fixation, bone
510(k) Number K113109
Device Name STRYKER RESORBABLE FIXATION SYSTEM
Applicant
Stryker
750 TRADE CENTER WAY
STE 200
PORAGE,  MI  49002
Applicant Contact Manish Patel
Correspondent
Stryker
750 TRADE CENTER WAY
STE 200
PORAGE,  MI  49002
Correspondent Contact Manish Patel
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
DZJ   EZX   HWC   MAI  
Date Received10/20/2011
Decision Date 12/23/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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