← Back to catalogue

Endeavor™ Stand-Alone Cervical IBF System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K250076

by Innovasis

Identifiers

510(k) Number
K250076 FDA 510(k)
FDA Product Code
OVE 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)

Endeavor™ Stand-Alone Cervical IBF System by Innovasis — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Innovasis

Sources (1)

  • FDA 510(k) K250076 24 fields · synced Jun 18, 2026