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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 K230517
Device Name Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor)
Applicant
Jarmon Medical, LLC (Dba Legends Orthopedics)
169 E Reynolds Rd., Suite 203b
Lexington,  KY  40517
Applicant Contact Jeremy Jarmon
Correspondent
Rogers Consulting
11110 Arranmore Cove
Roanoke,  IN  46783
Correspondent Contact W. Victoria Rogers
Regulation Number888.3040
Classification Product Code
MBI  
Date Received02/27/2023
Decision Date 09/11/2023
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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