Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF Cage— 510(k) K190363

Substantially Equivalent

Omnia Medical, LLC

FDA 510(k) clearance K190363 for Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF Cage, Substantially Equivalent on 2020-02-21. Applicant: Omnia Medical, LLC.

Clearance details

Applicant: Omnia Medical, LLC
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2019-02-15
Decision date: 2020-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morgantown,, WV, 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.