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

Clearance details

Applicant

Omnia Medical, LLC

Product code

Code MAX

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2019-02-15

Decision date

2020-02-21

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Morgantown,, WV, US

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• K261020 — Symmetrix L Spinal System2026-07-14
• K253420 — Admiral ACP System +18 more2026-07-01

• K242431 — Omnia Medical PsiF DNA System2025-06-06
• K240623 — Omnia Medical TiBrid-SA System2024-04-24
• K230424 — Omnia Medical Coupler-A Anterior Lumbar Plate System; Omnia Medical Coupler-L Lateral Lumbar Plate System2023-04-12
• K223321 — Omnia Medical Coupler-C Anterior Cervical Plate2023-03-13
• K212612 — Omnia Medical TiBrid-SC2022-11-15

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 →