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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
Applicant
Synthes (USA) Products, LLC
1303 Goshen Pkwy.
West Chester,  PA  19380
Applicant Contact REBECCA BLANK
Correspondent
Synthes (USA) Products, LLC
1303 Goshen Pkwy.
West Chester,  PA  19380
Correspondent Contact REBECCA BLANK
Regulation Number888.3040
Classification Product Code
HWC  
Date Received09/06/2011
Decision Date 12/05/2011
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
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