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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 K120390
Device Name SOLAFIX TWIST SCREW IMPLANT SYSTEM, SURGICAL INSTRUMENT SET
Original Applicant
SOLANA SURGICAL LLC
6363 poplar ave
suite 434
memphis,  TN  38119
Original Contact louise rocht
Regulation Number888.3040
Classification Product Code
HWC  
Date Received02/07/2012
Decision Date 04/10/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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