CENTERPIECE PLATE FIXATION SYSTEM

Orthosis, Spine, Plate, Laminoplasty, Metal

MEDTRONIC SOFAMOR DANEK, INC.

The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Centerpiece Plate Fixation System.

Pre-market Notification Details

Device IDK050082
510k NumberK050082
Device Name:CENTERPIECE PLATE FIXATION SYSTEM
ClassificationOrthosis, Spine, Plate, Laminoplasty, Metal
Applicant MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactRichard W Treharne, Phd.
CorrespondentRichard W Treharne, Phd.
MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeNQW  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-01-13
Decision Date2005-06-06
Summary:summary

NIH GUDID Devices

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