Citregen Tendon Interference Screw And Citrelock

Fastener, Fixation, Biodegradable, Soft Tissue

Acuitive Technologies

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

Pre-market Notification Details

Device IDK200725
510k NumberK200725
Device Name:Citregen Tendon Interference Screw And Citrelock
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant Acuitive Technologies 50 Commerce Drive Allendale,  NJ  07401
ContactJaclyn Docs
CorrespondentJanice Hogan
Hogan Lovells US. LLP 1735 Market Street Philadelphia,  PA  19103
Product CodeMAI  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-19
Decision Date2020-10-07

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