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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name screw, fixation, bone
510(k) Number K922788
Device Name BIOACTION LOW PROFILE SCREW SYSTEM
Original Applicant
ORTHOPAEDIC BIOSYSTEMS
7725 east redfield rd.
unit 102
scottsdale,  AZ  85260
Original Contact chip kabrud
Regulation Number888.3040
Classification Product Code
HWC  
Date Received06/09/1992
Decision Date 03/12/1993
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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