FDA.reportPublic FDA data

510(k) K231649

Device
Intraosseous Fusion Device System
Applicant
Auxano Medical, LLC
510(k) number
K231649
Product code
HWC
Decision
Substantially Equivalent (SESE)
Decision date
2023-09-29
Date received
2023-06-06
Regulation
888.3040
Classification name
Screw, Fixation, Bone
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jennifer Hazou
Address
8006 Katherine Blvd. Brecksville OH US 44141 44141

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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