Parcus GFS II And GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, And GFS Ultimate Hip

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 Gfs Ii And Gfs Mini, Gfs Naked, Gfs Ultimate, Gfs Btb, Atlas, Synd-ez Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, And Gfs Ultimate Hip.

Pre-market Notification Details

Device IDK202259
510k NumberK202259
Device Name:Parcus GFS II And GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, And GFS Ultimate Hip
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant Parcus Medical, LLC 6423 Parkland Drive Sarasota,  FL  34243
ContactPaul Vagts
CorrespondentPaul Vagts
Parcus Medical, LLC 6423 Parkland Drive Sarasota,  FL  34243
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-10
Decision Date2020-10-28

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