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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 K181843
Device Name MLP Special Locking Bone Plate System
Applicant
Maxxion Medical, LLC / Baumer SA
201, S. Biscayne Blvd., Suite 1200
Miami,  FL  33131
Applicant Contact Bruno Baumer
Correspondent
Medical Products International
4241 Wildwood Landing
North Charleston,  SC  29420
Correspondent Contact Larry Petersen
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received07/11/2018
Decision Date 03/04/2019
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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