FDA 510(k)

Endeavor Stand-Alone Cervical IBF System

K-Number: K250076 · 2025-09-25

Decision Date2025-09-25

Product CodeOVE

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Endeavor Stand-Alone Cervical IBF System is a medical device manufactured by Innovasis. It received FDA 510(k) clearance on 2025-09-25 under approval number K250076. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endeavor Stand-Alone Cervical IBF System?

Endeavor Stand-Alone Cervical IBF System is a medical device that received FDA 510(k) clearance on 2025-09-25. It is manufactured by Innovasis. The 510(k) number is K250076.

When was Endeavor Stand-Alone Cervical IBF System approved by the FDA?

Endeavor Stand-Alone Cervical IBF System received FDA 510(k) clearance on 2025-09-25, under approval number K250076.

What company makes Endeavor Stand-Alone Cervical IBF System?

Endeavor Stand-Alone Cervical IBF System is manufactured by Innovasis.

What is the FDA product code for Endeavor Stand-Alone Cervical IBF System?

The FDA product code for Endeavor Stand-Alone Cervical IBF System is OVE.

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Related Devices (Code: OVE)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.