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Data / Medical devices / United States / Symbiont Logistics, LLC

Symbiont Logistics, LLC: FDA-registered device maker in Phoenix, AZ, United States, 3 510(k) clearances

Symbiont Logistics, LLC is registered with the FDA (registration 2032381) in Phoenix, AZ, United States. It lists 7 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 1, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
2032381
FEI number
3003355324
Address
302 East University Drive Suite 301, Phoenix, AZ, United States, 85004
Owner or operator
Hanger, Inc (9007290)
Roles
Complaint file establishment, Manufacturer, Repackager or relabeler
First device listed
March 1, 1993
Registered through
2026
Brand names listed
AFO, Articulated Plastic, AFO, Crow Walker, AFO, Laminated Solid Ankle, AFO, Leather Gauntlet, AFO, Metal Leather Double Uprights, AFO, Metal Leather Single Upright, AFO, Plastic Double Upright, AFO, Plastic Standard and more

Devices it lists

DeviceProduct codeClassRoleSource
Joint, Knee, External BraceITQ1Manufactureraccessdata.fda.gov
Orthosis, CranialMVA2Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Orthosis, Cranial, Laser ScanOAN2Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Orthosis, Limb BraceIQI1Manufactureraccessdata.fda.gov
Orthosis, ThoracicIPT1Complaint file establishment, Manufactureraccessdata.fda.gov
Orthosis, Truncal/Orthosis, LimbMRI1Complaint file establishment, Manufactureraccessdata.fda.gov
Prosthesis, Thigh Socket, External ComponentISS1Manufactureraccessdata.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
July 1, 2022K203134Hanger Cranial Band 3DMVASubstantially EquivalentSymbion Logistics, LLCaccessdata.fda.gov
January 9, 2008K072566HANGER CRANIAL BANDOANSubstantially EquivalentHanger Prosthetics & Orthotics, Inc.accessdata.fda.gov
December 8, 2000K001669HANGER CRANIAL BANDMVASubstantially EquivalentHanger Orthopedic Group, Inc.accessdata.fda.gov

Compare with other makers

Updated July 1, 2022. 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.