Hexanium ACIF— 510(k) K221578

Substantially Equivalent

Spinevision, S.A.S.

FDA 510(k) clearance K221578 for Hexanium ACIF, Substantially Equivalent on 2022-11-14. Applicant: Spinevision, S.A.S..

Clearance details

Applicant: Spinevision, S.A.S.
Product code: Code OVE
Advisory panel: Orthopedic
Date received: 2022-06-01
Decision date: 2022-11-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Antony, FR

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.