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    FDA ALL ENFORCEMENT LETTERS AND INVESTIGATIONS FOR ALLOGRAFT GRAFTLINK CONSTRUCT BY ARTHREX AND LIFENET HEALTH

    FDA ALL ENFORCEMENT LETTERS AND INVESTIGATIONS FOR ALLOGRAFT GRAFTLINK CONSTRUCT BY ARTHREX AND LIFENET HEALTH

    $69.00 USD
    $69.00 USD
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    Original Request: All warning letters, untitled letters, Form 483s, and It Has Come to Our Attention (IHCTOA) letters associated with the medical device Allograft GraftLink® Construct, marketed by Arthrex Inc., at 1370 Creekside Blvd., Naples, FL 34108-1945, and/or manufactured by LifeNet Health, at 1864 Concert Dr., Virginia Beach, VA 23453, and the outcome of any closed investigation(s) by CDRH into the Allograft GraftLink® Construct, marketed by Arthrex Inc. and/or manufactured by LifeNet Health.
    Tags: MedTech, 483, 2020
    • Status: Pending Fast-Track Request
    • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

    NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.

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