ActiFlip

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.

Pre-market Notification Details

Device IDK212739
510k NumberK212739
Device Name:ActiFlip
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant Parcus Medical LLC. 6423 Parkland Drive Sarasota,  FL  34243
ContactCalen Souther
CorrespondentCalen Souther
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 Received2021-08-30
Decision Date2021-10-06

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