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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K230623
Device Name KITE Distal Fibula Kit
Applicant
Intrauma S.P.A
Via Genova 19
Rivoli (To),  IT 10098
Applicant Contact Piero Costa
Correspondent
Intrauma S.P.A
Via Genova 19
Rivoli (To),  IT 10098
Correspondent Contact Stefano Pullega
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HWC   KTT  
Date Received03/06/2023
Decision Date 09/01/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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