DEPUY GLOBAL UNITE SHOULDER SYSTEM

Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

DEPUY (IRELAND)

The following data is part of a premarket notification filed by Depuy (ireland) with the FDA for Depuy Global Unite Shoulder System.

Pre-market Notification Details

Device IDK133834
510k NumberK133834
Device Name:DEPUY GLOBAL UNITE SHOULDER SYSTEM
ClassificationProsthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Applicant DEPUY (IRELAND) LOUGHBEG RINGASKIDDY Co. Cork,  IE Ireland
ContactKellie Myers
CorrespondentKellie Myers
DEPUY (IRELAND) LOUGHBEG RINGASKIDDY Co. Cork,  IE Ireland
Product CodeKWS  
Subsequent Product CodeHSD
Subsequent Product CodePHX
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-12-17
Decision Date2014-04-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10603295433224 K133834 000
10603295004363 K133834 000
10603295004370 K133834 000
10603295004417 K133834 000
10603295004424 K133834 000
10603295004431 K133834 000
10603295004639 K133834 000
10603295004646 K133834 000
10603295004653 K133834 000
10603295004790 K133834 000
10603295004806 K133834 000
10603295004813 K133834 000
10603295430568 K133834 000
10603295430575 K133834 000
10603295433194 K133834 000
10603295433217 K133834 000
10603295004356 K133834 000

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