FDA.report

510(k) K252959

Device
WRISTAR MultiAx Distal Radius Kit
Applicant
Intrauma S.P.A
510(k) number
K252959
Product code
HRS
Decision
Substantially Equivalent (SESE)
Decision date
2025-11-12
Date received
2025-09-16
Regulation
888.3030
Classification name
Plate, Fixation, Bone
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Stefano Pullega
Address
Via A. Meucci 5 Bruino (To) IT 10090 10090

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
08056693002144MULTIAX SCREWINTRAUMA SPA2025-11-27
08056693001949WRISTAR MULTIAXINTRAUMA SPA2025-11-27
08056693001956WRISTAR MULTIAXINTRAUMA SPA2025-11-27
08056693001963WRISTAR MULTIAXINTRAUMA SPA2025-11-27
08056693001970WRISTAR MULTIAXINTRAUMA SPA2025-11-27
08056693001987WRISTAR MULTIAXINTRAUMA SPA2025-11-27
08056693001994WRISTAR MULTIAXINTRAUMA SPA2025-11-27
08056693002007WRISTAR MULTIAXINTRAUMA SPA2025-11-27
08056693002014WRISTAR MULTIAXINTRAUMA SPA2025-11-27
08056693002083MULTIAX SCREWINTRAUMA SPA2025-11-27
08056693002090MULTIAX SCREWINTRAUMA SPA2025-11-27
08056693002106MULTIAX SCREWINTRAUMA SPA2025-11-27
08056693002113MULTIAX SCREWINTRAUMA SPA2025-11-27
08056693002120MULTIAX SCREWINTRAUMA SPA2025-11-27
08056693002137MULTIAX SCREWINTRAUMA SPA2025-11-27
08056693028137WRISTAR MULTIAXINTRAUMA SPA2025-11-27
08056693002151MULTIAX SCREWINTRAUMA SPA2025-11-27
08056693002168MULTIAX SCREWINTRAUMA SPA2025-11-27
08056693002175MULTIAX SCREWINTRAUMA SPA2025-11-27
08056693002182MULTIAX SCREWINTRAUMA SPA2025-11-27
08056693002199MULTIAX SCREWINTRAUMA SPA2025-11-27
08056693027857WRISTAR MULTIAXINTRAUMA SPA2025-11-27
08056693027864WRISTAR MULTIAXINTRAUMA SPA2025-11-27
08056693027871WRISTAR MULTIAXINTRAUMA SPA2025-11-27
08056693027888WRISTAR MULTIAXINTRAUMA SPA2025-11-27
08056693027895WRISTAR MULTIAXINTRAUMA SPA2025-11-27
08056693027901WRISTAR MULTIAXINTRAUMA SPA2025-11-27
08056693027918WRISTAR MULTIAXINTRAUMA SPA2025-11-27
08056693027925WRISTAR MULTIAXINTRAUMA SPA2025-11-27

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