510(k) K250076

Endeavor Stand-Alone Cervical IBF System by Innovasis — Product Code OVE

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 25, 2025
Date Received: January 10, 2025
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Intervertebral Fusion Device With Integrated Fixation, Cervical
Device Class: Class II
Regulation Number: 888.3080
Review Panel: OR
Submission Type

Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

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Other clearances for product code OVE

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K251431 — FIX-C PEEK ACIF SA System (June 27, 2025)
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K242928 — Tesera-k SC System (April 10, 2025)
K243188 — CYLOX® ST (February 11, 2025)
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