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FDA 510(k)

Reselute Tibial Nail

K-Number: K253517 · 2026-03-10

ApplicantReselute, Inc.
Decision Date2026-03-10
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Reselute Tibial Nail is a medical device manufactured by Reselute, Inc.. It received FDA 510(k) clearance on 2026-03-10 under approval number K253517. 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 Reselute Tibial Nail?

Reselute Tibial Nail is a medical device that received FDA 510(k) clearance on 2026-03-10. It is manufactured by Reselute, Inc.. The 510(k) number is K253517.

When was Reselute Tibial Nail approved by the FDA?

Reselute Tibial Nail received FDA 510(k) clearance on 2026-03-10, under approval number K253517.

What company makes Reselute Tibial Nail?

Reselute Tibial Nail is manufactured by Reselute, Inc..

What is the FDA product code for Reselute Tibial Nail?

The FDA product code for Reselute Tibial Nail 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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