Expandable Lumbar Fusion Cage (Type I,Type II)— 510(k) K232069

Substantially Equivalent

Shanghai Reach Medical Instrument Co, Ltd.

FDA 510(k) clearance K232069 for Expandable Lumbar Fusion Cage (Type I,Type II), Substantially Equivalent on 2023-11-29. Applicant: Shanghai Reach Medical Instrument Co, Ltd..

Clearance details

Applicant: Shanghai Reach Medical Instrument Co, Ltd.
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2023-07-12
Decision date: 2023-11-29
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.