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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 K131186
Device Name SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEM
Applicant
Synthes (USA) Products, LLC
1301 Goshen Pkwy.
West Chester,  PA  19380
Applicant Contact REBECCA G REITER
Correspondent
Synthes (USA) Products, LLC
1301 Goshen Pkwy.
West Chester,  PA  19380
Correspondent Contact REBECCA G REITER
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received04/25/2013
Decision Date 10/08/2013
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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