E3D-C Interbody System— 510(k) K262094

Name: FDA 510(k) clearance K262094
Creator: U.S. Food and Drug Administration
Published: 2026-07-22

Substantially Equivalent

Evolution Spine

FDA 510(k) clearance K262094 for E3D-C Interbody System, Substantially Equivalent on 2026-07-22. Applicant: Evolution Spine. Device class: 2.

Clearance details

Applicant: Evolution Spine
Product code: Code OVE
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2026-06-22
Decision date: 2026-07-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OVE

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K261279 — DeltaNEC Interbody System2026-06-22
K252982 — CONDUIT ZERO-P VA Secured Spacer System2026-06-18
K260036 — NeckTune 3D SA Cervical Cage2026-06-15
K260660 — SABER-C System2026-04-27
K253213 — SAGI Cervical Cage System2026-04-20

More clearances from Evolution Spine

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K260038 — E3D-C Interbody System2026-02-04
K250167 — Evolution Spine Navigation Instruments2025-08-18
K241846 — E3D-C Interbody System2024-08-12
K240368 — E3D-A Interbody System2024-05-15
K232432 — E3D-A Interbody System2024-01-30

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.