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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 K220833
Device Name Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL
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 J7W3J6
Correspondent Contact Robert A Poggie
Regulation Number888.3030
Classification Product Code
MAI  
Subsequent Product Code
MBI  
Date Received03/22/2022
Decision Date 11/04/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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