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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 K080241
Device Name DDS STABILIZATION SYSTEM
Applicant
Paradigm Spine, LLC
1331 H St. NW
12th Floor
Washington,  DC  20005
Applicant Contact JUSTIN EGGLETON
Correspondent
Paradigm Spine, LLC
1331 H St. NW
12th Floor
Washington,  DC  20005
Correspondent Contact JUSTIN EGGLETON
Regulation Number888.3070
Classification Product Code
NQP  
Date Received01/31/2008
Decision Date 11/28/2008
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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