JULIET® LL Lateral Lumbar Cage— 510(k) K161888

Substantially Equivalent

Spineart

FDA 510(k) clearance K161888 for JULIET® LL Lateral Lumbar Cage, Substantially Equivalent on 2016-09-12. Applicant: Spineart.

Clearance details

Applicant: Spineart
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2016-07-11
Decision date: 2016-09-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Geneva, CH

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.