FDA 510(K) K190929, xvision Spine system (XVS)
FDA 510(K) K190929, xvision Spine system (XVS)
Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K190929
Device Name xvision Spine system (XVS)
Applicant Augmedics Ltd.
Regulation Number 882.4560
Classification Product Code OLO
Date Received 04/09/2019
Decision Date 12/20/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Total pages: 3,697
Fully redacted pages: 2,948
Content pages: 749
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