FDA 510(k) Applications Submitted by Premia Spine Ltd.

FDA 510(k) Number Submission Date Device Name Applicant
K231844 06/22/2023 ProMISÖ Fixation System Premia Spine Ltd.
K170061 01/06/2017 ProMISÖ Fixation System Premia Spine Ltd.
K150380 02/13/2015 ProMIS Fixation System Premia Spine Ltd.
K182598 09/20/2018 VersaLinkÖ Fixation System Premia Spine Ltd.


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