The Citrefix Knotless Suture Anchor

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 The Citrefix Knotless Suture Anchor.

Pre-market Notification Details

Device IDK203334
510k NumberK203334
Device Name:The Citrefix Knotless Suture Anchor
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 J7v7p2
Product CodeMAI  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-12
Decision Date2021-02-05

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