1 0

    FDA 510(k), K203714, NuVasive Thoracolumbar Interbody Systems

    FDA 510(k), K203714, NuVasive Thoracolumbar Interbody Systems

    $1,976.54 USD
    $1,976.54 USD
    Sale Sold out

    Device Classification Name: Intervertebral Fusion Device With Bone Graft, Lumbar
    510(k) Number: K203714
    Device Name: NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty
    Applicant: NuVasive, Incorporated
    Regulation Number: 888.3080
    Classification Product Code: MAX  
    Subsequent Product Codes: MQV, OVD, PHM
    Date Received: 12/21/2020
    Decision Date: 12/23/2021
    Decision: Substantially Equivalent (SESE)
    Regulation Medical Specialty: Orthopedic

    Total Pages: 3,045
    Fully Redacted Pages: 1,915
    Content Pages: 1,130

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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