CAPSTONE R SPINAL SYSTEM

Intervertebral Fusion Device With Bone Graft, Lumbar

MEDTRONIC SOFAMOR DANEK

The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Capstone R Spinal System.

Pre-market Notification Details

Device IDK103731
510k NumberK103731
Device Name:CAPSTONE R SPINAL SYSTEM
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis,  TN  38132
ContactThao Phan
CorrespondentThao Phan
MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-12-22
Decision Date2011-07-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994846266 K103731 000
00613994803061 K103731 000
00763000096908 K103731 000
00763000096892 K103731 000
00763000096885 K103731 000
00763000096878 K103731 000
00763000096915 K103731 000

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