THREADED CEMENT RESTRICTOR (CR) TITANIUM

Prosthesis, Hip, Cement Restrictor

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 Threaded Cement Restrictor (cr) Titanium.

Pre-market Notification Details

Device IDK011443
510k NumberK011443
Device Name:THREADED CEMENT RESTRICTOR (CR) TITANIUM
ClassificationProsthesis, Hip, Cement Restrictor
Applicant MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactRichard Treharne
CorrespondentRichard Treharne
MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeJDK  
CFR Regulation Number878.3300 [🔎]
DecisionSe - With Limitations (SESU)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-05-11
Decision Date2001-08-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00885074000770 K011443 000

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