Endeavor Stand-Alone Cervical IBF System— 510(k) K250076

Name: FDA 510(k) clearance K250076
Creator: U.S. Food and Drug Administration
Published: 2025-09-25

Substantially Equivalent

Innovasis

FDA 510(k) clearance K250076 for Endeavor Stand-Alone Cervical IBF System, Substantially Equivalent on 2025-09-25. Applicant: Innovasis. Device class: 2.

Clearance details

Applicant: Innovasis
Product code: Code OVE
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2025-01-10
Decision date: 2025-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OVE

view all

K261882 — Pisces-SC Standalone Cervical Interbody System2026-08-21
K261451 — ZSAlign Cervical Interbody System2026-07-31
K262094 — E3D-C Interbody System2026-07-22
K261279 — DeltaNEC Interbody System2026-06-22
K252982 — CONDUIT ZERO-P VA Secured Spacer System2026-06-18

More clearances from Innovasis

view all

K250603 — AxTiHA® Stand-Alone ALIF System2025-03-24

Adverse events under product code OVE

product code OVE

Injury: 293
Malfunction: 710
Total: 1,003

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.