MOUNTAINEER OCT SPINAL SYSTEM

Orthosis, Spondylolisthesis Spinal Fixation

DEPUY SPINE, INC.

The following data is part of a premarket notification filed by Depuy Spine, Inc. with the FDA for Mountaineer Oct Spinal System.

Pre-market Notification Details

Device IDK080828
510k NumberK080828
Device Name:MOUNTAINEER OCT SPINAL SYSTEM
ClassificationOrthosis, Spondylolisthesis Spinal Fixation
Applicant DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham,  MA  02767
ContactLisa Gilman
CorrespondentLisa Gilman
DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham,  MA  02767
Product CodeMNH  
Subsequent Product CodeKWP
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-03-25
Decision Date2008-06-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10705034158587 K080828 000
10705034158570 K080828 000
10705034158563 K080828 000
10705034158556 K080828 000
10705034158549 K080828 000
10705034158532 K080828 000

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