MODIFICATION TO TOWNLEY PEDICLE SCREW PLATING SYSTEM

Orthosis, Spinal Pedicle Fixation

SOFAMOR DANEK USA,INC.

The following data is part of a premarket notification filed by Sofamor Danek Usa,inc. with the FDA for Modification To Townley Pedicle Screw Plating System.

Pre-market Notification Details

Device IDK982686
510k NumberK982686
Device Name:MODIFICATION TO TOWNLEY PEDICLE SCREW PLATING SYSTEM
ClassificationOrthosis, Spinal Pedicle Fixation
Applicant SOFAMOR DANEK USA,INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactBailey Lipscomb
CorrespondentBailey Lipscomb
SOFAMOR DANEK USA,INC. 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeMNI  
Subsequent Product CodeKWP
Subsequent Product CodeMNH
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-08-03
Decision Date1998-08-07
Summary:summary

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