Hexanium TLIF— 510(k) K210359

Substantially Equivalent

Spinevision, S.A.S.

FDA 510(k) clearance K210359 for Hexanium TLIF, Substantially Equivalent on 2021-03-10. Applicant: Spinevision, S.A.S..

Clearance details

Applicant: Spinevision, S.A.S.
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2021-02-08
Decision date: 2021-03-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Batiment E, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

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.