MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

DANEK MEDICAL, INC.

The following data is part of a premarket notification filed by Danek Medical, Inc. with the FDA for Modification To Zplate-atl Anterior Fixation System.

Pre-market Notification Details

Device IDK982875
510k NumberK982875
Device Name:MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant DANEK MEDICAL, INC. 1800 PYRAMID PL. Memphis,  TN  38132
ContactRichard W Treharne
CorrespondentRichard W Treharne
DANEK MEDICAL, INC. 1800 PYRAMID PL. Memphis,  TN  38132
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-08-14
Decision Date1999-01-19
Summary:summary

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