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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
Original Applicant
SAFE ORTHOPAEDICS
parc des bellevues
allee r.luxembourg-bat californie
eragny sur oise,  FR 95610
Original 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 (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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