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    FDA 510(k) K181980, OsseoScrew System, by Alphatec Spine, Inc.

    FDA 510(k) K181980, OsseoScrew System, by Alphatec Spine, Inc.

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    Device Classification Name: Thoracolumbosacral Pedicle Screw System
    510(k) Number: K181980
    Device Name: OsseoScrew System
    Applicant: Alphatec Spine, Inc.
    Regulation Number: 888.3070
    Classification Product Code: NKB
    Date Received: 07/25/2018
    Decision Date: 09/25/2018
    Decision: Substantially Equivalent (SESE)
    Regulation Medical Specialty: Orthopedic
    510k Review Panel: Orthopedic

    Total number of pages: 534
    Fully redacted pages: 370
    Content pages: 164

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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