K-number	K250076
Device name	Endeavor Stand-Alone Cervical IBF System
Applicant	Innovasis
Product code	OVE
Device class	Class II
Decision date	Sep 25, 2025
Decision	Substantially Equivalent
Regulation	888.3080

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Endeavor Stand-Alone Cervical IBF System is an interbody fusion device indicated for anterior cervical interbody fusion in skeletally mature patients with single-level degenerative disc disease from C2-T1. The device is a stand-alone implant with integrated fixation screws, used with bone graft material via an anterior surgical approach in patients who have failed at least six weeks of non-operative treatment.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Endeavor Stand-Alone Cervical IBF System

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Endeavor Stand-Alone Cervical IBF System