FDA.report

510(k) K261145

Device
Avanti Distal Elbow ORIF System
Applicant
Avanti Orthopaedics, LLC
510(k) number
K261145
Product code
HRS
Decision
Substantially Equivalent (SESE)
Decision date
2026-05-09
Date received
2026-04-07
Regulation
888.3030
Classification name
Plate, Fixation, Bone
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Doug Patterson
Address
1814 Gilpin Ave. Wilmington DE US 19806 19806

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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