MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides

Pedicle Screw Placement Guide

Medacta Inernational SA

The following data is part of a premarket notification filed by Medacta Inernational Sa with the FDA for Myspine S2-alar/alar-iliac Pedicle Screw Placement Guides.

Pre-market Notification Details

Device IDK200792
510k NumberK200792
Device Name:MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides
ClassificationPedicle Screw Placement Guide
Applicant Medacta Inernational SA Strada Regina Castel San Pietro,  CH Ch-6874
ContactStefano Baj
CorrespondentChris Lussier
Medacta USA 3973 Delp Street Memphis,  TN  38118
Product CodePQC  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-26
Decision Date2020-10-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630971255791 K200792 000
07630971255784 K200792 000
07630971255777 K200792 000
07630971255760 K200792 000
07630040728355 K200792 000
07630040728348 K200792 000

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