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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, for degenerative disc disease
510(K) Number K121299
Device Name STERISPINEPS PEDICLE SCREW, STERISPINEPS ROD
Applicant
SAFE ORTHOPAEDICS
parc des bellevues
allee r.luxembourg-bat californie
eragny sur oise, 
Contact pierre dumouchel
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNH   MNI  
Date Received04/30/2012
Decision Date 07/30/2012
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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