Artfx Medical LLC
Jax, FL, US
ARTFX MEDICAL LLC appears in FDA device records in Jax, FL. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Artfx Medical LLC between 2022 and 2024. The busiest year on record is 2024, with 3. The most recent is 2024, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K242939 | ARTFX Trauma Bone Plate and Screw System | HRS | Substantially Equivalent | |
| K240889 | ARTFX Lumbar PEEK Cages | MAX | Substantially Equivalent | |
| K240893 | ARTFX MEDICAL Cervical PEEK Cages | ODP | Substantially Equivalent | |
| K212220 | ArtFX Spinal Fixation System | NKB | Substantially Equivalent | |
| K211718 | Venus Cervical Plate System | KWQ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3017435639 | 3017435639 | ARTFX MEDICAL LLC | 50 n laura st 25th floor, JAX, FL 32202 US | 2026 | and 7 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NBHAccessories, Arthroscopic
- LYQAccessories, Fixation, Spinal Intervertebral Body
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- KIHDispenser, Cement
- HXPInstrument, Bending Or Contouring
- HWNInstrument, Compression
- HAOInstrument, Surgical, Non-Powered
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- LXHOrthopedic Manual Surgical Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- HRSPlate, Fixation, Bone
- HSBRod, Fixation, Intramedullary And Accessories
- HWCScrew, Fixation, Bone
- NKBThoracolumbosacral Pedicle Screw System
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain