Cleared Traditional

Endeavor? Stand-Alone Cervical IBF System

K250076 · Innovasis · Orthopedic

Sep 2025

Decision

258d

Days

Class 2

Risk

About This 510(k) Submission

K250076 is an FDA 510(k) clearance for the Endeavor? Stand-Alone Cervical IBF System, a Intervertebral Fusion Device With Integrated Fixation, Cervical (Class II — Special Controls, product code OVE), submitted by Innovasis (Salt Lake City, US). The FDA issued a Cleared decision on September 25, 2025, 258 days after receiving the submission on January 10, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K250076 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 10, 2025
Decision Date	September 25, 2025
Days to Decision	258 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OVE — Intervertebral Fusion Device With Integrated Fixation, Cervical
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	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.