Avanti Distal Elbow ORIF System
K-Number: K261145 · 2026-05-09
ApplicantAvanti Orthopaedics, LLC
Decision Date2026-05-09
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Avanti Distal Elbow ORIF System is a medical device manufactured by Avanti Orthopaedics, LLC. It received FDA 510(k) clearance on 2026-05-09 under approval number K261145. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Avanti Distal Elbow ORIF System?
Avanti Distal Elbow ORIF System is a medical device that received FDA 510(k) clearance on 2026-05-09. It is manufactured by Avanti Orthopaedics, LLC. The 510(k) number is K261145.
When was Avanti Distal Elbow ORIF System approved by the FDA?
Avanti Distal Elbow ORIF System received FDA 510(k) clearance on 2026-05-09, under approval number K261145.
What company makes Avanti Distal Elbow ORIF System?
Avanti Distal Elbow ORIF System is manufactured by Avanti Orthopaedics, LLC.
What is the FDA product code for Avanti Distal Elbow ORIF System?
The FDA product code for Avanti Distal Elbow ORIF System is HRS.
Related Devices (Code: HRS)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.