Ti3Z Lumbar Interbody System— 510(k) K212811

Substantially Equivalent

Zavation Medical Products, LLC

FDA 510(k) clearance K212811 for Ti3Z Lumbar Interbody System, Substantially Equivalent on 2022-04-12. Applicant: Zavation Medical Products, LLC.

Clearance details

Applicant: Zavation Medical Products, LLC
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2021-09-03
Decision date: 2022-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flowood, MS, 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.