TOWNLEY PEDICLE SCREW PLATING SYSTEM

Orthosis, Spinal Pedicle Fixation

DANEK MEDICAL, INC.

The following data is part of a premarket notification filed by Danek Medical, Inc. with the FDA for Townley Pedicle Screw Plating System.

Pre-market Notification Details

Device IDK970599
510k NumberK970599
Device Name:TOWNLEY PEDICLE SCREW PLATING SYSTEM
ClassificationOrthosis, Spinal Pedicle Fixation
Applicant DANEK MEDICAL, INC. 1800 PYRAMID PL. Memphis,  TN  38132
ContactRichard W Treharne, Ph.d.
CorrespondentRichard W Treharne, Ph.d.
DANEK MEDICAL, INC. 1800 PYRAMID PL. Memphis,  TN  38132
Product CodeMNI  
Subsequent Product CodeKWP
Subsequent Product CodeMNH
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-02-18
Decision Date1998-03-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00721902877148 K970599 000
00721902659799 K970599 000

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