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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 K230544
Device Name SnugFit All-Suture Anchor extension
Applicant
Medacta International S.A.
Strada Regina
Castel San Pietro,  CH 6874
Applicant Contact Stefano Baj
Correspondent
Medacta USA
3973 Delp St.
Memphis,  TN  38118
Correspondent Contact Christopher Lussier
Regulation Number888.3040
Classification Product Code
MBI  
Date Received02/28/2023
Decision Date 04/17/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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