Halis Lumbar Cage System, Lydia Anterior Lumbar Fusion System, Dica Direction Changeable Lumbar Cage System, KEYSTONE Cage System— 510(k) K230872

Substantially Equivalent

Shanghai Sanyou Medical Co, Ltd.

FDA 510(k) clearance K230872 for Halis Lumbar Cage System, Lydia Anterior Lumbar Fusion System, Dica Direction Changeable Lumbar Cage System, KEYSTONE Cage System, Substantially Equivalent on 2023-12-12. Applicant: Shanghai Sanyou Medical Co, Ltd..

Clearance details

Applicant: Shanghai Sanyou Medical Co, Ltd.
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2023-03-30
Decision date: 2023-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jiading District, 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.