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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Nonabsorbable, Synthetic, Polyethylene
510(k) Number K253145
Device Name Pre-Sutured Tendon
Applicant
Rti Surgical, Inc.
11621 Research Cir.
Alachua,  FL  32615
Applicant Contact Ellen Rounds
Correspondent
Rti Surgical, Inc.
11621 Research Cir.
Alachua,  FL  32615
Correspondent Contact Ellen Rounds
Regulation Number878.5000
Classification Product Code
GAT  
Date Received09/25/2025
Decision Date 10/22/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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