PARCUS 3.5MM PEEK CF PUSH-IN SUTURE ANCHOR

Screw, Fixation, Bone

PARCUS MEDICAL, LLC

The following data is part of a premarket notification filed by Parcus Medical, Llc with the FDA for Parcus 3.5mm Peek Cf Push-in Suture Anchor.

Pre-market Notification Details

Device IDK102326
510k NumberK102326
Device Name:PARCUS 3.5MM PEEK CF PUSH-IN SUTURE ANCHOR
ClassificationScrew, Fixation, Bone
Applicant PARCUS MEDICAL, LLC 839 SOUTH NEENAH AVE. Sturgeon Bay,  WI  54235
ContactBarion Bracy
CorrespondentBarion Bracy
PARCUS MEDICAL, LLC 839 SOUTH NEENAH AVE. Sturgeon Bay,  WI  54235
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-08-17
Decision Date2010-11-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816342022255 K102326 000
00816342022163 K102326 000
00816342024532 K102326 000

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