The FDA questioned whether PureGen is within the classification of human cell, tissue and cellular or tissue-based products that the FDA regulates. Alphatec Spine and Parcell Laboratories plan on working with the FDA to address its questions about PureGen and will share the clinical outcomes gathered to date.
PureGen Osteoprogenitor Cell Allograft has been successfully implanted in more than 500 patients, primarily during lumbar and cervical spine fusions, and no adverse events have been reported.
Read the release about PureGen.
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Alphatec Spine Signs Agreement With Merlot OrthopediX for Spine Surgery Technology
Alphatec Spine Receives 510(k) Clearance for Solus System
Alphatec Spine to Answer FDA's Questions on PureGen Product for Spinal FusionsWritten by Laura Dyrda | Wednesday, 27 July 2011 17:15
Alphatec Holdings has commented on a Food and Drug Administration letter sent to Parcell Laboratories regarding Alphatec Spine's PureGen Osteoprogenitor Cell Allograft, according to a company news release.
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