E3D-C Interbody System— 510(k) K241846

Substantially Equivalent

Evolution Spine

FDA 510(k) clearance K241846 for E3D-C Interbody System, Substantially Equivalent on 2024-08-12. Applicant: Evolution Spine.

Clearance details

Applicant: Evolution Spine
Product code: Code OVE
Advisory panel: Orthopedic
Date received: 2024-06-26
Decision date: 2024-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

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.