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    FDA 510(k), K140106, S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM

    FDA 510(k), K140106, S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM

    $89.00 USD
    $89.00 USD
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    510(K) Number: K140106
    Device Name: S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
    Manufacturer:
    Device Classification Name: Intervertebral Fusion Device With Integrated Fixation, Lumbar
    Regulation Number: 888.3080
    Classification Product Code: OVD
    Date Received: 01/15/2014
    Decision Date: 03/27/2014
    Regulation Medical Specialty: Orthopedic

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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