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 a medical device manufactured by Intrauma S.P.A. It received FDA 510(k) clearance on 2025-11-12 under approval 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. It is manufactured by Intrauma S.P.A. The 510(k) number is K252959.
When was WRISTAR MultiAx Distal Radius Kit approved by the FDA?
WRISTAR MultiAx Distal Radius Kit received FDA 510(k) clearance on 2025-11-12, under approval number K252959.
What company makes WRISTAR MultiAx Distal Radius Kit?
WRISTAR MultiAx Distal Radius Kit is manufactured by Intrauma S.P.A.
What is the FDA product code for WRISTAR MultiAx Distal Radius Kit?
The FDA product code for WRISTAR MultiAx Distal Radius Kit is HRS.
Related Clinical Trials
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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.