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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K163323
Device Name Dolphix® External Fixation System MR Conditional
Applicant
Citieffe S.R.L.
Via Armaroli, 21
Calderara Di Reno,  IT 400012
Applicant Contact Stefano Pullega
Correspondent
Thelma S.R.L
Via Saragat, 5
Imola (Bo),  IT 40026
Correspondent Contact Marisa Testa
Regulation Number888.3030
Classification Product Code
KTT  
Subsequent Product Code
JDW  
Date Received11/25/2016
Decision Date 03/20/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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