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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, Biodegradable, Soft Tissue
510(k) Number K203493
Device Name MectaLock Extension
Applicant
Medacta International S.A.
Strada Regina
Castel San Pietro (Ch),  CH CH-6874
Applicant Contact Stefano Baj
Correspondent
Medacta USA
3973 Delp St.
Memphis,  TN  38118
Correspondent Contact Chris Lussier
Regulation Number888.3030
Classification Product Code
MAI  
Subsequent Product Code
MBI  
Date Received11/27/2020
Decision Date 02/22/2021
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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