ANATOMIC PEEK PTC CERVICAL FUSION 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 Anatomic Peek Ptc Cervical Fusion System.

Pre-market Notification Details

Device IDK133653
510k NumberK133653
Device Name:ANATOMIC PEEK PTC CERVICAL FUSION SYSTEM
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactJulie Bassett
CorrespondentJulie Bassett
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 Received2013-11-27
Decision Date2014-04-28
Summary:summary

NIH GUDID Devices

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