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PubMed

Food and Drug Administration authorization of spine surgery devices: a 2-decade analysis of clearance trends, regulatory pathways, and market entry.

PMID: 42967350 ·

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JournalNeurosurgical focus
Year
PMID42967350

Abstract

In this study, the authors aimed to characterize trends in the regulatory authorization of spine surgery devices in the United States, including device category composition, regulatory pathway use, decision timelines, and patterns of new market entry. Authorizations related to spine surgery issued between January 1, 2000, and December 31, 2023, were identified from the publicly available US Food and Drug Administration (FDA) 510(k), Premarket Approval (PMA), De Novo, and Humanitarian Device Exem

Official Source

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