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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name appliance, fixation, spinal interlaminal
510(k) Number K112595
Device Name COFLEX-F
Applicant
PARADIGM SPINE, LLC
505 PARK AVENUE, 14TH FLOOR
NEW YORK,  NY  10022
Applicant Contact MARC VISCOGLIOSI
Correspondent
PARADIGM SPINE, LLC
505 PARK AVENUE, 14TH FLOOR
NEW YORK,  NY  10022
Correspondent Contact MARC VISCOGLIOSI
Regulation Number888.3050
Classification Product Code
KWP  
Date Received09/07/2011
Decision Date 02/13/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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