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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name appliance, fixation, spinal interlaminal
510(k) Number K971289
Device Name SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)
Original Applicant
OSTEOTECH, INC.
51 james way
eatontown,  NJ  07724
Original Contact christopher talbot
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Code
MNH  
Date Received04/07/1997
Decision Date 06/18/1997
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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