MySpine Pedicle Screw Placement Guides - LP

Orthosis, Spinal Pedicle Fixation

Medacta International SA

The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Myspine Pedicle Screw Placement Guides - Lp.

Pre-market Notification Details

Device IDK153273
510k NumberK153273
Device Name:MySpine Pedicle Screw Placement Guides - LP
ClassificationOrthosis, Spinal Pedicle Fixation
Applicant Medacta International SA Strada Regina Castel San Pietro,  CH Ch 6874
ContactMichael G Loiterman
CorrespondentRoshana Ahmed
Mapi USA, Inc. 2343 Alexandria Drive Suite 100 Lexington,  KY  40504
Product CodeMNI  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-11-12
Decision Date2016-06-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630030877605 K153273 000
07630030877476 K153273 000
07630030877469 K153273 000
07630030877452 K153273 000
07630030877445 K153273 000
07630030877438 K153273 000
07630030877421 K153273 000
07630040716888 K153273 000
07630040716864 K153273 000
07630040716840 K153273 000
07630040716826 K153273 000
07630030877483 K153273 000
07630030877490 K153273 000
07630030877599 K153273 000
07630030877582 K153273 000
07630030877575 K153273 000
07630030877568 K153273 000
07630030877551 K153273 000
07630030877544 K153273 000
07630030877537 K153273 000
07630030877520 K153273 000
07630030877513 K153273 000
07630030877506 K153273 000
07630040716802 K153273 000
07630040716789 K153273 000
07630971262706 K153273 000
07630971262690 K153273 000
07630971262683 K153273 000
07630971257801 K153273 000
07630971257795 K153273 000
07630971257788 K153273 000
07630971257771 K153273 000
07630040716529 K153273 000
07630040716505 K153273 000
07630040716482 K153273 000
07630971262713 K153273 000
07630040716567 K153273 000
07630040716765 K153273 000
07630040716741 K153273 000
07630040716727 K153273 000
07630040716703 K153273 000
07630040716680 K153273 000
07630040716666 K153273 000
07630040716642 K153273 000
07630040716628 K153273 000
07630040716604 K153273 000
07630040716581 K153273 000
07630040716468 K153273 000
07630030877612 K153273 000
07630030878091 K153273 000
07630030877964 K153273 000
07630030877957 K153273 000
07630030877940 K153273 000
07630030877933 K153273 000
07630030877926 K153273 000
07630030877919 K153273 000
07630030877902 K153273 000
07630030877896 K153273 000
07630030877889 K153273 000
07630030877872 K153273 000
07630030877971 K153273 000
07630030877988 K153273 000
07630030878084 K153273 000
07630030878077 K153273 000
07630030878060 K153273 000
07630030878053 K153273 000
07630030878046 K153273 000
07630030878039 K153273 000
07630030878022 K153273 000
07630030878015 K153273 000
07630030878008 K153273 000
07630030877995 K153273 000
07630030877865 K153273 000
07630030877858 K153273 000
07630030877728 K153273 000
07630030877711 K153273 000
07630030877704 K153273 000
07630030877698 K153273 000
07630030877681 K153273 000
07630030877674 K153273 000
07630030877667 K153273 000
07630030877650 K153273 000
07630030877643 K153273 000
07630030877636 K153273 000
07630030877735 K153273 000
07630030877742 K153273 000
07630030877841 K153273 000
07630030877834 K153273 000
07630030877827 K153273 000
07630030877810 K153273 000
07630030877803 K153273 000
07630030877797 K153273 000
07630030877780 K153273 000
07630030877773 K153273 000
07630030877766 K153273 000
07630030877759 K153273 000
07630030877629 K153273 000

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