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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinous Process Plate
510(k) Number K153302
Device Name coflex-IF
Applicant
Paradigm Spine, LLC
505 Park Ave. 14th Floor
New York,  NY  10022
Applicant Contact Marc Viscogliosi
Correspondent
Musculoskeletal Clinical Regulatory Advisers, LLC
1331 H St. NW
12th Floor
Washington,  DC  20005
Correspondent Contact Justin Eggleton
Regulation Number888.3050
Classification Product Code
PEK  
Date Received11/13/2015
Decision Date 09/08/2016
Decision Substantially Equivalent (SESE)
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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