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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 K122931
Device Name S-LOK PSS SYSTEM
Applicant
SPINAL USA
1001 oakwood blvd
round rock,  TX  78681
Contact j.d. webb
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received09/24/2012
Decision Date 11/20/2012
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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