FDA.reportPublic FDA data

510(k) K251791

Device
Auxano® Wedge Fixation System
Applicant
Auxano Medical, LLC
510(k) number
K251791
Product code
PLF
Decision
Substantially Equivalent (SESE)
Decision date
2025-09-25
Date received
2025-06-11
Regulation
888.3030
Classification name
Bone Wedge
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Stephen Mezget
Address
8006 Katherine Blvd. Brecksville OH US 44141 44141

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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