Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, And Citrelock ACL

Fastener, Fixation, Biodegradable, Soft Tissue

Acuitive Technologies, Inc.

The following data is part of a premarket notification filed by Acuitive Technologies, Inc. with the FDA for Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline Acl, And Citrelock Acl.

Pre-market Notification Details

Device IDK220833
510k NumberK220833
Device Name:Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, And Citrelock ACL
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant Acuitive Technologies, Inc. 50 Commerce Drive Allendale,  NJ  07401
ContactMatthew Poggie
CorrespondentRobert A Poggie
BioVera, Inc. 65 Promenade Saint Louis Notre-Dame-de-L'lle-Perrot,  CA J7W3J6
Product CodeMAI  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-22
Decision Date2022-11-04

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