PERIMETER C SPINAL SYSTEM

Intervertebral Fusion Device With Bone Graft, Cervical

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 C Spinal System.

Pre-market Notification Details

Device IDK132584
510k NumberK132584
Device Name:PERIMETER C SPINAL SYSTEM
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactMichael Scott
CorrespondentMichael Scott
MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-16
Decision Date2013-12-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169200746 K132584 000
00643169200609 K132584 000
00643169200616 K132584 000
00643169200623 K132584 000
00643169200630 K132584 000
00643169200647 K132584 000
00643169200654 K132584 000
00643169200661 K132584 000
00643169200678 K132584 000
00643169200685 K132584 000
00643169200692 K132584 000
00643169200708 K132584 000
00643169200715 K132584 000
00643169200722 K132584 000
00643169200739 K132584 000
00643169200593 K132584 000

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