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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, Biodegradable, Soft Tissue
510(k) Number K213958
Device Name Bioabsorbable Anchor
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 Number888.3030
Classification Product Code
MAI  
Date Received12/17/2021
Decision Date 04/08/2022
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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