JTS EXTENDEABLE IMPLANT

Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

STANMORE IMPLANTS WORLDWIDE LTD.

The following data is part of a premarket notification filed by Stanmore Implants Worldwide Ltd. with the FDA for Jts Extendeable Implant.

Pre-market Notification Details

Device IDK092138
510k NumberK092138
Device Name:JTS EXTENDEABLE IMPLANT
ClassificationProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Applicant STANMORE IMPLANTS WORLDWIDE LTD. 555 THIRTEENTH ST, NW Washington,  DC  20004
ContactGerard J Prud'homme
CorrespondentGerard J Prud'homme
STANMORE IMPLANTS WORLDWIDE LTD. 555 THIRTEENTH ST, NW Washington,  DC  20004
Product CodeKRO  
CFR Regulation Number888.3510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-07-15
Decision Date2011-03-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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