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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
510(k) Number K222501
Device Name Regeneten Bioinductive Implant
Applicant
Smith and Nephew, Inc.
150 Minuteman Rd.
Andover,  MA  01810
Applicant Contact Jenna Horsley
Correspondent
Smith and Nephew, Inc.
150 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact Jenna Horsley
Regulation Number878.3300
Classification Product Code
OWY  
Subsequent Product Code
ORQ  
Date Received08/18/2022
Decision Date 05/11/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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