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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 K221468
Device Name Citregen™ Tendon Interference Screw (TIS), Citrelock™ Tendon Fixation Device, Citrespline™ and Citrelock™ ACL Implants
Applicant
Acuitive Technologies, Inc.
50 Commerce Dr.
Alendale,  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  
Date Received05/20/2022
Decision Date 02/14/2023
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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