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FDA 510(k)

Active Intramedullary (AIM) Tibial Nail System

K-Number: K252025 · 2026-03-04

ApplicantSatori Orthopaedics, Inc.
Decision Date2026-03-04
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Active Intramedullary (AIM) Tibial Nail System is a medical device manufactured by Satori Orthopaedics, Inc.. It received FDA 510(k) clearance on 2026-03-04 under approval number K252025. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Active Intramedullary (AIM) Tibial Nail System?

Active Intramedullary (AIM) Tibial Nail System is a medical device that received FDA 510(k) clearance on 2026-03-04. It is manufactured by Satori Orthopaedics, Inc.. The 510(k) number is K252025.

When was Active Intramedullary (AIM) Tibial Nail System approved by the FDA?

Active Intramedullary (AIM) Tibial Nail System received FDA 510(k) clearance on 2026-03-04, under approval number K252025.

What company makes Active Intramedullary (AIM) Tibial Nail System?

Active Intramedullary (AIM) Tibial Nail System is manufactured by Satori Orthopaedics, Inc..

What is the FDA product code for Active Intramedullary (AIM) Tibial Nail System?

The FDA product code for Active Intramedullary (AIM) Tibial Nail System is HSB.

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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.

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