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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 K141045
Device Name MBD PLATE SYSTEM
Applicant
Mbd Medical, LLC
575 Eighth Ave.
Suite 1212
New York,  NY  10018
Applicant Contact JENNIFER A DAUDELIN
Correspondent
Mbd Medical, LLC
575 Eighth Ave.
Suite 1212
New York,  NY  10018
Correspondent Contact JENNIFER A DAUDELIN
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received04/23/2014
Decision Date 06/30/2014
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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