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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 K120163
Device Name ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEM
Applicant
ACUTE INNOVATIONS LLC
21421 NW JACOBSON RD.
SUITE 700
HILLSBORO,  OR  97124
Applicant Contact MARIAH KNIGHT
Correspondent
ACUTE INNOVATIONS LLC
21421 NW JACOBSON RD.
SUITE 700
HILLSBORO,  OR  97124
Correspondent Contact MARIAH KNIGHT
Regulation Number888.3030
Classification Product Code
HRS  
Date Received01/19/2012
Decision Date 02/17/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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