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FDA 510(k)

WRISTAR MultiAx Distal Radius Kit

K-Number: K252959 · 2025-11-12

ApplicantIntrauma S.P.A
Decision Date2025-11-12
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

WRISTAR MultiAx Distal Radius Kit is the device name listed in this FDA 510(k) record. The listed applicant is Intrauma S.P.A. It received FDA 510(k) clearance on 2025-11-12 under 510(k) number K252959. 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 WRISTAR MultiAx Distal Radius Kit?

WRISTAR MultiAx Distal Radius Kit is a medical device that received FDA 510(k) clearance on 2025-11-12. The listed applicant is Intrauma S.P.A. The 510(k) number is K252959.

When did WRISTAR MultiAx Distal Radius Kit receive FDA 510(k) clearance?

WRISTAR MultiAx Distal Radius Kit received FDA 510(k) clearance on 2025-11-12, under 510(k) number K252959.

Who is the listed applicant for WRISTAR MultiAx Distal Radius Kit?

The FDA 510(k) record lists Intrauma S.P.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WRISTAR MultiAx Distal Radius Kit?

The FDA product code for WRISTAR MultiAx Distal Radius Kit is HRS.

Other records listing Intrauma S.P.A as applicant

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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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