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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 K203334
Device Name The Citrefix Knotless Suture Anchor
Applicant
Acuitive Technologies, Inc.
50 Commerce Drive
Allendale,  NJ  07401
Applicant Contact Matthew Poggie
Correspondent
BioVera, Inc
65 Promenade Saint Louis
Notre-Dame-de-L'lle-Perrot,  CA J7V7P2
Correspondent Contact Robert A Poggie
Regulation Number888.3030
Classification Product Code
MAI  
Subsequent Product Code
MBI  
Date Received11/12/2020
Decision Date 02/05/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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