Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)— 510(k) K232996

Substantially Equivalent

Shanghai Iatrical-Ti Technologies CO , Ltd.

FDA 510(k) clearance K232996 for Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF), Substantially Equivalent on 2024-09-06. Applicant: Shanghai Iatrical-Ti Technologies CO , Ltd..

Clearance details

Applicant: Shanghai Iatrical-Ti Technologies CO , Ltd.
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2023-09-22
Decision date: 2024-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

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.