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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 the device name listed in this FDA 510(k) record. The listed applicant is Reselute, Inc.. It received FDA 510(k) clearance on 2026-03-10 under 510(k) 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. The listed applicant is Reselute, Inc.. The 510(k) number is K253517.

When did Reselute Tibial Nail receive FDA 510(k) clearance?

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

Who is the listed applicant for Reselute Tibial Nail?

The FDA 510(k) record lists Reselute, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reselute Tibial Nail?

The FDA product code for Reselute Tibial Nail is HSB.

Related Devices (Code: HSB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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