FDA 510(k), K140167, RENAISSANCE X SYSTEM

FDA 510(k), K140167, RENAISSANCE X SYSTEM

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510(K) Number: K140167
Device Name: RENAISSANCE X SYSTEM
Manufacturer: MAZOR ROBOTICS LTD
Device Classification Name: orthopedic stereotaxic instrument
Regulation Number: 882.4560
Classification Product Code: OLO
Date Received: 01/23/2014
Decision Date: 09/10/2014
Regulation Medical Specialty: Neurology

Total pages: 2,713
Fully redacted pages: 2,568
Content pages: 145

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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.

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