Parcus Knotless PEEK And PEEK CF Push-In Suture Anchor

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 Knotless Peek And Peek Cf Push-in Suture Anchor.

Pre-market Notification Details

Device IDK193295
510k NumberK193295
Device Name:Parcus Knotless PEEK And PEEK CF Push-In Suture Anchor
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
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-27
Decision Date2020-01-23

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