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Data / Medical devices / United States / Armis Biopharma, Inc.

Armis Biopharma, Inc.: FDA-registered device maker in Fort Collins, CO, United States, 2 510(k) clearances

Armis Biopharma, Inc. is registered with the FDA (registration 3020745223) in Fort Collins, CO, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 25, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3020745223
Address
2401 Research Blvd Ste 205, Fort Collins, CO, United States, 80526
Owner or operator
Armis Biopharma, Inc. (10083045)
Roles
Complaint file establishment, Specification developer
First device listed
October 21, 2021
Registered through
2026
Brand names listed
Armis VeriCyn Wound Wash, VeriFixx (TM) Small Bone Implant

Devices it lists

DeviceProduct codeClassRoleSource
Dressing, Wound, DrugFROUComplaint file establishment, Specification developeraccessdata.fda.gov
Lavage, JetFQH2Complaint file establishment, Specification developeraccessdata.fda.gov
Pin, Fixation, SmoothHTY2Complaint file establishment, Specification developeraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
May 25, 2023K220759Armis VeriCyn Wound WashFQHSubstantially EquivalentArmis Biopharma, Inc.accessdata.fda.gov
November 17, 2020K202777VeriFixx™ Small Bone ImplantHTYSubstantially EquivalentArmis Biopharma, Inc.accessdata.fda.gov

Compare with other makers

Updated May 25, 2023. 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.