FDA 510(k) Applications Submitted by HELENE PLAS

FDA 510(k) Number Submission Date Device Name Applicant
K160124 01/20/2016 LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System SpineVision S.A.
K130302 02/07/2013 SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. POLYAXIAL PEDICLE SCREW FIXAT SPINEVISION, S.A.
K153783 12/31/2015 SpaceVision« PLIF, SpaceVision« OLIF, SpaceVision« TLIF SpineVision S.A.


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