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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
Original Applicant
1331 h street nw
12th floor
washington,  DC  20005
Original Contact justin eggleton
Regulation Number888.3070
Classification Product Code
Date Received10/22/2007
Decision Date 01/24/2008
Decision se - with limitations (SESU)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No