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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 K091944
Device Name MODIFICATION TO: DSS STABILIZATION SYSTEM
Applicant
Paradigm Spine, LLC
1331 H St. NW
12th Floor
Washington,  DC  20005
Applicant Contact ADAM HERDER
Correspondent
Paradigm Spine, LLC
1331 H St. NW
12th Floor
Washington,  DC  20005
Correspondent Contact ADAM HERDER
Regulation Number888.3070
Classification Product Code
NQP  
Subsequent Product Codes
MNH   MNI   NKB  
Date Received06/30/2009
Decision Date 08/03/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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