Data / Medical devices / United States / Infigo Medical
Infigo Medical: FDA-registered device maker in Miami, FL, United States, 7 510(k) clearances
Infigo Medical is registered with the FDA (registration 3022159082) in Miami, FL, United States. It lists 15 device types. The FDA files 7 510(k) clearances under its listings, the newest dated October 2, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3022159082
- Address
- 66 west flagler street suite 900, Miami, FL, United States, 33130
- Owner or operator
- INFIGO MEDICAL (10084742)
- Roles
- Manufacturer for export, Repackager or relabeler
- First device listed
- March 29, 2022
- Registered through
- 2026
- Brand names listed
- INFIGO INSTRUMENT, INFIGO INSTRUMENT TRAUMA, INFIGO SPINAL FIXATION SYSTEM, INFIGO TRAUMA SYSTEM
Devices it lists
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 |
|---|---|---|---|---|---|---|
| October 2, 2024 | K240889 | ARTFX Lumbar PEEK Cages | MAX | Substantially Equivalent | Artfx Medical | accessdata.fda.gov |
| June 28, 2024 | K240893 | ARTFX MEDICAL Cervical PEEK Cages | ODP | Substantially Equivalent | Artfx Medical | accessdata.fda.gov |
| April 20, 2023 | K212220 | ArtFX Spinal Fixation System | NKB | Substantially Equivalent | Artfx Medical, LLC | accessdata.fda.gov |
| October 6, 2022 | K211892 | ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) | MQP | Substantially Equivalent | Arftx Medical, LLC | accessdata.fda.gov |
| June 28, 2022 | K211718 | Venus Cervical Plate System | KWQ | Substantially Equivalent | Artfx Medical, LLC | accessdata.fda.gov |
| December 17, 2015 | K151062 | WASTON Metallic Intramedullary Nail System | HSB | Substantially Equivalent | Changzhou Waston Medical Appliance Co., Ltd. | accessdata.fda.gov |
| August 10, 2015 | K151057 | WASTON Metallic Bone Plate and Screw Systems | HRS | Substantially Equivalent | Changzhou Waston Medical Appliance Co., Ltd. | accessdata.fda.gov |
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Updated October 2, 2024. 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.