For the other claims, the applicant provided only background evidence, specifically retrospective studies, which describe findings for a predicate device, the Axoguard Nerve Protector TM , which received FDA 510(k) clearance on January 10, 2014, not the nominated device, the Axoguard HA+ Nerve Protector TM
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10.2174/138161211796196954 [DOI] [PubMed] [Google Scholar] Sikiric P., Seiwerth S., Rucman R., Turkovic B., Rokotov D