AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, 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 Actiflip Naked, Actiflip Cinch, Actiflip Whip, Gfs Ultimate Hip.

Pre-market Notification Details

Device IDK192750
510k NumberK192750
Device Name:AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip
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
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-30
Decision Date2020-01-16

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