FDA 510(k), K120368, CAPSTONE CONTROL SPINAL SYSTEM

FDA 510(k), K120368, CAPSTONE CONTROL SPINAL SYSTEM

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510(K) Number: K120368
Device Name: CAPSTONE CONTROL SPINAL SYSTEM
Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC.
Device Classification Name: intervertebral fusion device with bone graft, lumbar
Regulation Number: 888.3080
Classification Product Code: MAX
Date Received: 02/06/2012
Decision Date: 04/09/2012
Regulation Medical Specialty: Orthopedic

Total pages: 652
Fully redacted pages: 461
Content pages: 191

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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