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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 K092078
Device Name OPTILOCK PERIARTICULAR PLATING
Applicant
Biomet Trauma
100 Interface Pkwy.
Parsippany,  NJ  07054
Applicant Contact SHIKHA GOLA
Correspondent
Biomet Trauma
100 Interface Pkwy.
Parsippany,  NJ  07054
Correspondent Contact SHIKHA GOLA
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received07/09/2009
Decision Date 08/05/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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