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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 K120651
Device Name STABILIZ FIXATION SYSTEM
Original Applicant
STABILIZ ORTHOPAEDICS, LLC
3225 arch st
philadelphia,  PA  19104
Original Contact douglas l cerynik, md
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received03/02/2012
Decision Date 11/27/2012
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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