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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name orthosis, spondylolisthesis spinal fixation
510(k) Number K120491
Device Name DSS STABILIZATION SYSTEM-RIGID
Applicant
PARADIGM SPINE, LLC
1331 H STREET NW
12TH FLOOR
WASHINGTON,  DC  20005
Applicant Contact MICHELLE MCDONOUGH
Correspondent
PARADIGM SPINE, LLC
1331 H STREET NW
12TH FLOOR
WASHINGTON,  DC  20005
Correspondent Contact MICHELLE MCDONOUGH
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Codes
MNI   NKB   NQP  
Date Received02/17/2012
Decision Date 05/09/2012
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
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