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    FDA 510(k), K023087, GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS)

    FDA 510(k), K023087, GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS)

    $89.00 USD
    $89.00 USD
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    510(K) Number: K023087
    Device Name: GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS)
    Manufacturer:
    Device Classification Name: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
    Regulation Number: 888.3510
    Classification Product Code: KRO
    Date Received: 09/17/2002
    Decision Date: 12/16/2002
    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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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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