Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors

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 V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors.

Pre-market Notification Details

Device IDK201083
510k NumberK201083
Device Name:Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-23
Decision Date2020-07-23

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.