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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 K070823
Device Name GROWTH CONTROL PLATING SYSTEM
Applicant
Biomet Trauma
100 Interface Pkwy.
Parsippany,  NJ  07054
Applicant Contact SUSAN ALEXANDER
Correspondent
Biomet Trauma
100 Interface Pkwy.
Parsippany,  NJ  07054
Correspondent Contact SUSAN ALEXANDER
Regulation Number888.3030
Classification Product Code
HRS  
Date Received03/26/2007
Decision Date 05/07/2007
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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