FDA 510(k)

Xpert Ankle

K-Number: K261511 · 2026-07-28

Decision Date2026-07-28

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Xpert Ankle is the device name listed in this FDA 510(k) record. The listed applicant is Newclip Technics. It received FDA 510(k) clearance on 2026-07-28 under 510(k) number K261511. 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 Xpert Ankle?

Xpert Ankle is a medical device that received FDA 510(k) clearance on 2026-07-28. The listed applicant is Newclip Technics. The 510(k) number is K261511.

When did Xpert Ankle receive FDA 510(k) clearance?

Xpert Ankle received FDA 510(k) clearance on 2026-07-28, under 510(k) number K261511.

Who is the listed applicant for Xpert Ankle?

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

What is the FDA product code for Xpert Ankle?

The FDA product code for Xpert Ankle is HRS.

Other records listing Newclip Technics as applicant

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.

K261191Alians Elbow S K261038Xpert PFP K253906Xpert Hand K250767Newclip Patient-matched instrumentation non sterile PSI K250155Xpert Knee K243912Newclip Patient-matched instrumentation non sterile PSI

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Related Devices (Code: HRS)

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.