JTS EXTENDIBLE DISTAL FEMORAL 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 Extendible Distal Femoral Implant.

Pre-market Notification Details

Device IDK133152
510k NumberK133152
Device Name:JTS EXTENDIBLE DISTAL FEMORAL 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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-11-22
Decision Date2014-01-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B278TMKTPEXSM50 K133152 000
B278MKTPSTD200 K133152 000
B278MKTPSTD50 K133152 000
B278SMLTBC000 K133152 000
B278SMLTBC010 K133152 000
B278SMLTBC020 K133152 000
B278SMMLTB010 K133152 000
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B278SMMLTBC000 K133152 000
B278TMKTPEXSM100 K133152 000
B278TMKTPEXSM200 K133152 000
B278TMKTPSM10R0 K133152 000
B278TMKTPSM15R0 K133152 000
B278TMKTPSM20R0 K133152 000
B278TMKTPSM5R0 K133152 000
B278TMKTPSTD10R0 K133152 000
B278TMKTPSTD15R0 K133152 000
B278TMKTPSTD20R0 K133152 000
B278MKTPSTD150 K133152 000
B278MKTPSTD100 K133152 000
B278IMTPRHPEXSM0 K133152 000
B278IMTPRHPSM0 K133152 000
B278IMTPRHPSTD0 K133152 000
B278IMTPRMFHEXSM0 K133152 000
B278IMTPRMFHSM0 K133152 000
B278IMTPRMFHSTD0 K133152 000
B278IMTRFH0 K133152 000
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B278IMTRRHMSM0 K133152 000
B278IMTRRHMSTD0 K133152 000
B278IMTRRHPEXSM0 K133152 000
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B278IMTRRHPSTD0 K133152 000
B278MKTPSM100 K133152 000
B278MKTPSM150 K133152 000
B278MKTPSM200 K133152 000
B278MKTPSM50 K133152 000
B278TMKTPSTD5R0 K133152 000
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05060296236335 K133152 000
05060296236175 K133152 000

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