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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K120356
Device Name NCS FISH-FIT MD SYSTEM FISH-FIT MD COMPASS MD
Applicant
Ncs Lab Srl
Via Pola Esterna 4/12
Carpi,  IT 41012
Applicant Contact MATTEO MANTOVANI
Correspondent
Ncs Lab Srl
Via Pola Esterna 4/12
Carpi,  IT 41012
Correspondent Contact MATTEO MANTOVANI
Regulation Number888.3040
Classification Product Code
MBI  
Date Received02/06/2012
Decision Date 12/11/2012
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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