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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 K252647
Device Name Tapestry Biointegrative Implant
Applicant
Embody, Inc.
4211 Monarch Way, Suite 500
Norfolk,  VA  23508
Applicant Contact Brianna Schehr
Correspondent
Embody, Inc.
4211 Monarch Way, Suite 500
Norfolk,  VA  23508
Correspondent Contact Brianna Schehr
Regulation Number878.3300
Classification Product Code
OWY  
Date Received08/21/2025
Decision Date 09/19/2025
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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