Medical Device Manufacturer · US , Sturgeon Bay , WI

Parcus Medical, LLC - FDA 510(k) Cleared Devices

28 submissions · 28 cleared · Since 2009

Recent clearances: Parcus Synd-EZ SS, X-Twist PEEK Suture Anchor, ActiFlip

28

Total

28

Cleared

0

Denied

FDA 510(k) Regulatory Record - Parcus Medical, LLC Orthopedic ✕

28 devices

1-12 of 28

Cleared Jul 26, 2022

Parcus Synd-EZ SS

Orthopedic · 64d

Cleared May 19, 2022

X-Twist PEEK Suture Anchor

Orthopedic · 30d

Cleared Oct 06, 2021

Orthopedic · 37d

Cleared Feb 22, 2021

Parcus Titanium Interference Screws

Orthopedic · 161d

Cleared Oct 28, 2020

Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ...

Orthopedic · 79d

Cleared Jul 23, 2020

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

Orthopedic · 91d

Cleared Jan 23, 2020

Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor

Orthopedic · 57d

Cleared Jan 16, 2020

AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip

Orthopedic · 108d

Cleared Nov 22, 2019

Parcus Synd-EZ SS

Orthopedic · 30d

Cleared Nov 02, 2019

Parcus Knotless AP Suture Anchors

Orthopedic · 31d

Cleared Oct 09, 2019

Parcus Synd-EZ Ti

Orthopedic · 98d

Cleared Apr 24, 2019

Orthopedic · 64d