FDA 510(K) K153302 COFLEX-IF CLEARED 09/08/2016
FDA 510(K) K153302 COFLEX-IF CLEARED 09/08/2016
Device Classification Name Spinous Process Plate
510(k) Number K153302
Device Name coflex-IF
Applicant PARADIGM SPINE, LLC
Regulation Number 888.3050
Classification Product Code PEK
Date Received 11/13/2015
Decision Date 09/08/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Total pages: 1,102
Fully redacted pages: 821
Content pages: 281
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