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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 K230036
Device Name Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand )
Applicant
Rti Surgical, Inc.
11621 Research Cir.
Alachua,  FL  32615
Applicant Contact Lynne Witkowski
Correspondent
Rti Surgical, Inc.
11621 Research Cir.
Alachua,  FL  32615
Correspondent Contact Ellen Rounds
Regulation Number878.5000
Classification Product Code
GAT  
Date Received12/27/2022
Decision Date 06/23/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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