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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 K261770
Device Name Suture Button Repair System
Applicant
Skeletal Dynamics, Inc.
7300 N. Kendall Dr.
Suite 800
Miami,  FL  33156
Applicant Contact Alexandra Rodriguez
Correspondent
Skeletal Dynamics, Inc.
7300 N. Kendall Dr.
Suite 800
Miami,  FL  33156
Correspondent Contact Alexandra Rodriguez
Regulation Number888.3040
Classification Product Code
MBI  
Date Received05/29/2026
Decision Date 07/29/2026
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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