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FDA 510(k) Applications Submitted by Ron Sacher
FDA 510(k) Number
Submission Date
Device Name
Applicant
K150380
02/13/2015
ProMIS Fixation System
Premia Spine Ltd.
K191854
07/10/2019
Premia Spine XL Instruments
Premia Spine, Ltd.
K182598
09/20/2018
VersaLinkÖ Fixation System
Premia Spine Ltd.
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