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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name screw, fixation, bone
510(k) Number K112583
Device Name SYNTHES CORTICAL SCREWS
Original Applicant
SYNTHES (USA) PRODUCTS LLC
1303 goshen parkway
west chester,  PA  19380
Original Contact rebecca blank
Regulation Number888.3040
Classification Product Code
HWC  
Date Received09/06/2011
Decision Date 12/05/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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