Omnia Medical, LLC: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Omnia Medical, LLC” (first 2017, latest 2025), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 86 days. Since 2017 the median was 86 days, against 97 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 1 | 86 |
| 2018 | 0 | — |
| 2019 | 2 | 49 |
| 2020 | 3 | 206 |
| 2021 | 0 | — |
| 2022 | 1 | 455 |
| 2023 | 2 | 94 |
| 2024 | 1 | 50 |
| 2025 | 1 | 294 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Omnia Medical, LLC took a median 86 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 97 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 | 2 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | 2 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 2 | 2 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| MQP | Spinal Vertebral Body Replacement Device | 1 | 1 |
| OUR | Sacroiliac Joint Fixation | 1 | 1 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 1 | 1 |
| PLR | Spinal Vertebral Body Replacement Device - Cervical | 1 | 1 |
Review panels
- Orthopedic (11)
Most recent Omnia Medical, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242431 | Omnia Medical PsiF DNA System | OUR | 2025-06-06 | 294 |
| K240623 | Omnia Medical TiBrid-SA System | OVD | 2024-04-24 | 50 |
| K230424 | Omnia Medical Coupler-A Anterior Lumbar Plate System; Omnia Medical Coupler-L Lateral Lumbar Plate System | KWQ | 2023-04-12 | 54 |
| K223321 | Omnia Medical Coupler-C Anterior Cervical Plate | KWQ | 2023-03-13 | 133 |
| K212612 | Omnia Medical TiBrid-SC | OVE | 2022-11-15 | 455 |
| K203207 | Omnia Medical TiBrid-SA | OVD | 2020-12-23 | 54 |
| K192096 | Omnia Medical Trauma Screws | HWC | 2020-02-27 | 206 |
| K190363 | 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 | MAX | 2020-02-21 | 371 |
| K191778 | Omnia Medical VBR | PLR | 2019-08-28 | 57 |
| K183659 | Omnia Medical Rotary PLIF System | MAX | 2019-02-06 | 41 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Omnia Medical, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Omnia Spa (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Omnia Medical, LLC?
FDA lists 11 510(k) clearances under the applicant name “Omnia Medical, LLC” (first 2017, latest 2025), across 8 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Omnia Medical, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Omnia Medical, LLC is 86 days. Since 2017: 86 days, versus 97 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Omnia Medical, LLC?
The most frequent FDA product codes under this applicant name are KWQ (Appliance, Fixation, Spinal Intervertebral Body, 2); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 2); OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar, 2).
Next steps
- See all 11 Omnia Medical, LLC clearances with predicates and recalls
- Run predicate analysis for product code KWQ, Omnia Medical, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.