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Keos Anterior Cervical Interbody Fusion Device System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K212450

by Keos

Identifiers

510(k) Number
K212450 FDA 510(k)
FDA Product Code
ODP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3080 FDA 510(k)
Regulation Number
888.3080 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Keos Anterior Cervical Interbody Fusion Device System by Keos — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Keos

Sources (1)

  • FDA 510(k) K212450 24 fields · synced Jun 18, 2026