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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, Nondegradable, Soft Tissue
510(k) Number K232592
Device Name CITRELOCK® DUO
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’Ile-Perrot,  CA J7W3J6
Correspondent Contact Robert A. Poggie, PhD
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
MAI  
Date Received08/25/2023
Decision Date 09/20/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
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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