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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 K152253
Device Name Biomet Microfixation RibFix Blu Thoracic Fixation System
Applicant
BIOMET MICROFIXATION
1520 TRADEPORT DRIVE
JACKSONVILLE,  FL  32218
Applicant Contact LAUREN JASPER
Correspondent
BIOMET MICROFIXATION
1520 TRADEPORT DRIVE
JACKSONVILLE,  FL  32218
Correspondent Contact LAUREN JASPER
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received08/10/2015
Decision Date 03/24/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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