Data / Medical devices / United States / Veritas Medical Devices LLC
Veritas Medical Devices LLC: FDA-registered device maker in Southlake, TX, United States, 6 510(k) clearances
Veritas Medical Devices LLC is registered with the FDA (registration 3036042032) in Southlake, TX, United States. It lists 6 device types. The FDA files 6 510(k) clearances under its listings, the newest dated June 27, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3036042032
- Address
- 251 E Southlake Blvd, Southlake, TX, United States, 76092
- Owner or operator
- Veritas Medical Devices LLC (10092794)
- Roles
- Complaint file establishment
- First device listed
- February 2, 2026
- Registered through
- 2026
- Brand names listed
- Jeil Medical ARIX Ankle Distal Tibia System, Jeil Medical ARIX Cannulated Screw System, Jeil Medical ARIX System, Jeil Medical FIX-C 3D Ti ACIF System, Jeil Medical FIX-C PEEK ACIF SA System, Jeil Medical FIX-L PEEK PLIF and T-PLIF System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Complaint file establishment | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Complaint file establishment | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | 2 | Complaint file establishment | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Complaint file establishment | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Complaint file establishment | accessdata.fda.gov |
| Washer, Bolt, Nut, Non-Spinal, Metallic | NDG | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 27, 2025 | K251431 | FIX-C PEEK ACIF SA System | OVE | Substantially Equivalent | Jeil Medical Corporation | accessdata.fda.gov |
| June 12, 2025 | K243973 | FIX-L PEEK PLIF and T-PLIF System | MAX | Substantially Equivalent | Jeil Medical Corporation | accessdata.fda.gov |
| February 18, 2025 | K243915 | FIX-C 3D Ti ACIF System | ODP | Substantially Equivalent | Jeil Medical Corporation | accessdata.fda.gov |
| March 11, 2024 | K233912 | ARIX Cannulated Screw System | HWC | Substantially Equivalent | Jeil Medical Corporation | accessdata.fda.gov |
| December 14, 2023 | K231887 | ARIX Ankle Distal Tibia System | HRS | Substantially Equivalent | Jeil Medical Corporation | accessdata.fda.gov |
| November 20, 2018 | K181806 | ARIX Sternal System | HRS | Substantially Equivalent | Jeil Medical Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
- All makers of Plate, Fixation, Bone
- All makers of Screw, Fixation, Bone
- All makers of Washer, Bolt, Nut, Non-Spinal, Metallic
- All makers of Intervertebral Fusion Device With Integrated Fixation, Cervical
Updated June 27, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.