PERIMETER Interbody Fusion Device

Intervertebral Fusion Device With Bone Graft, Lumbar

Medtronic Sofamor Danek USA, Inc

The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc with the FDA for Perimeter Interbody Fusion Device.

Pre-market Notification Details

Device IDK160418
510k NumberK160418
Device Name:PERIMETER Interbody Fusion Device
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Medtronic Sofamor Danek USA, Inc 1800 Pyramid Place Memphis,  TN  38132
ContactAnkit K. Shah
CorrespondentAnkit K. Shah
Medtronic Sofamor Danek USA, Inc 1800 Pyramid Place Memphis,  TN  38132
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-02-16
Decision Date2016-03-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169583917 K160418 000
00643169584075 K160418 000
00643169584082 K160418 000
00643169584679 K160418 000
00643169584686 K160418 000
00643169584693 K160418 000
00643169584709 K160418 000
00643169584716 K160418 000
00643169584723 K160418 000
00643169584747 K160418 000
00643169584754 K160418 000
00643169584761 K160418 000
00643169584068 K160418 000
00643169584051 K160418 000
00643169583931 K160418 000
00643169583948 K160418 000
00643169583955 K160418 000
00643169583979 K160418 000
00643169583986 K160418 000
00643169583993 K160418 000
00643169584006 K160418 000
00643169584013 K160418 000
00643169584020 K160418 000
00643169584037 K160418 000
00643169584044 K160418 000
00643169584778 K160418 000
00643169584785 K160418 000
00643169584952 K160418 000
00643169584969 K160418 000
00643169584976 K160418 000
00643169584983 K160418 000
00643169584990 K160418 000
00643169585003 K160418 000
00643169585010 K160418 000
00643169585027 K160418 000
00643169585034 K160418 000
00643169585041 K160418 000
00643169585058 K160418 000
00643169584938 K160418 000
00643169584921 K160418 000
00643169584792 K160418 000
00643169584815 K160418 000
00643169584822 K160418 000
00643169584839 K160418 000
00643169584846 K160418 000
00643169584853 K160418 000
00643169584860 K160418 000
00643169584884 K160418 000
00643169584891 K160418 000
00643169584907 K160418 000
00643169584914 K160418 000
00643169585065 K160418 000

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