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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name posterior metal/polymer spinal system, fusion
510(K) Number K072969
Device Name DSS
Applicant
PARADIGM SPINE, LLC
1331 h street nw
12th floor
washington,  DC  20005
Contact justin eggleton
Regulation Number888.3070
Classification Product Code
NQP  
Date Received10/22/2007
Decision Date 01/24/2008
Decision substantially equivalent - with limitations (SU)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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