FDA 510(K) K190929, xvision Spine system (XVS)

FDA 510(K) K190929, xvision Spine system (XVS)

Regular price $1,382.58 USD
Regular price Sale price $1,382.58 USD
Sale Sold out

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

PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

View full details