Parcus Synd-EZ SS

Fastener, Fixation, Nondegradable, Soft Tissue

Parcus Medical, LLC

The following data is part of a premarket notification filed by Parcus Medical, Llc with the FDA for Parcus Synd-ez Ss.

Pre-market Notification Details

Device IDK192964
501k NumberK192964
Device Name:Parcus Synd-EZ SS
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant Parcus Medical, LLC 6423 Parkland Dr Sarasota,  FL  34243
ContactPaul Vagts
CorrespondentPaul Vagts
Parcus Medical, LLC 6423 Parkland Dr Sarasota,  FL  34243
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
501k Review PanelOrthopedic
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-23
Decision Date2019-11-22

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