Arthrex Synergy UHD4 System

Laparoscope, General & Plastic Surgery

ARTHREX, INC.

The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Synergy Uhd4 System.

Pre-market Notification Details

Device IDK153218
510k NumberK153218
Device Name:Arthrex Synergy UHD4 System
ClassificationLaparoscope, General & Plastic Surgery
Applicant ARTHREX, INC. 1370 CREEKSIDE BOULEVARD Naples,  OH  34108 -1945
ContactDavid L Rogers
CorrespondentDavid L Rogers
ARTHREX, INC. 1370 CREEKSIDE BOULEVARD Naples,  OH  34108 -1945
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-11-05
Decision Date2016-02-12
Summary:summary

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