HAnano InterFuse(R) Modular Interbody— 510(k) K242509

Substantially Equivalent

Next Orthosurgical

FDA 510(k) clearance K242509 for HAnano InterFuse(R) Modular Interbody, Substantially Equivalent on 2024-09-19. Applicant: Next Orthosurgical.

Clearance details

Applicant: Next Orthosurgical
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2024-08-22
Decision date: 2024-09-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Vista, CA, US

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.