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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name orthosis, spinal pedicle fixation
510(k) Number K130279
Device Name REFORM PEDICLE SCREW SYSTEM
Original Applicant
SPINAL USA
4628 northpark drive
colorado springs,  MS  39208
Original Contact meredith may
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   MNH  
Date Received02/05/2013
Decision Date 06/20/2013
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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