PARCUS 35 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS, PARCUS 45 KNOTLESS PEEK CF PUSH-IN 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 35 Knotless Peek Cf Push-in Suture Anchors, Parcus 45 Knotless Peek Cf Push-in Suture Anchors.

Pre-market Notification Details

Device IDK113730
510k NumberK113730
Device Name:PARCUS 35 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS, PARCUS 45 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant PARCUS MEDICAL, LLC 839 SOUTH NEENAH AVE. Sturgeon Bay,  WI  54235
ContactPaul Vagts
CorrespondentPaul Vagts
PARCUS MEDICAL, LLC 839 SOUTH NEENAH AVE. Sturgeon Bay,  WI  54235
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-12-19
Decision Date2012-01-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816342021166 K113730 000
00816342024136 K113730 000
00816342023788 K113730 000
00816342021173 K113730 000
00816342021159 K113730 000
00816342021142 K113730 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.