510(k) Report

FDA applicant

Omnia Medical, LLC

Morgantown,, WV11 decisions2017–20252 recalls

FDA records 11 decisions for Omnia Medical, LLC (Morgantown,, WV) from 2017 to 2025: 11 510(k) clearances. Most are in product codes KWQ (Appliance, Fixation, Spinal Intervertebral Body) and OVD (Intervertebral Fusion Device With Integrated…). Since 2016 its 510(k)s took a median of 86 days from receipt to decision, against 97 for FDA’s reviews in the same codes and years. Its devices cite 17 predicates, 3 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Omnia Medical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2017: 12019: 22020: 32022: 12023: 22024: 12025: 1
2017high 3 (2020) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

2in 2024

2024: 2
2017high 2 (2024) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Omnia Medical, LLC by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KWQAppliance, Fixation, Spinal Intervertebral Body2decisions
  • OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar2decisions
  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar2decisions
  • PLRSpinal Vertebral Body Replacement Device - Cervical1decision
  • OURSacroiliac Joint Fixation1decision
  • OVEIntervertebral Fusion Device With Integrated Fixation, Cervical1decision

Also: HWC (1), MQP (1).

How long do its 510(k) reviews take?

Since 2016, its 11 510(k)s took a median of 86 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 97 days; 6 of its 11 were faster than that.

Whose devices does it build on?

Its devices cite 17 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K191778Omnia Medical VBROmnia Medical, LLC · 20193cite it
  • K203207Omnia Medical TiBrid-SAOmnia Medical, LLC · 20201cites it
  • K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC · 20251cites it
  • K190363Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia…Omnia Medical, LLC · 20201cites it
  • K172323Omnia Medical VBROmnia Medical, LLC · 20171cites it

What has FDA decided for it lately?

  • K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC · 2025
  • K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC · 2024
  • K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral Lumbar Plate SystemOmnia Medical, LLC · 2023
  • K223321Omnia Medical Coupler-C Anterior Cervical PlateOmnia Medical, LLC · 2023
  • K212612Omnia Medical TiBrid-SCOmnia Medical, LLC · 2022
  • K203207Omnia Medical TiBrid-SAOmnia Medical, LLC · 20202 recalls
  • K192096Omnia Medical Trauma ScrewsOmnia Medical, LLC · 2020
  • K190363Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia…Omnia Medical, LLC · 2020

All 11 as Omnia Medical, LLC →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K203207TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers…Jul 15, 2024Class II
  • K203207TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30…Jul 15, 2024Class II

Other applicant names beginning “Omnia”

FDA records each applicant name separately; these may or may not be the same firm.

Omnia Spa 3