ENCORE HUMERAL SHOULDER STEM

Shoulder Prosthesis, Reverse Configuration

ENCORE MEDICAL, L.P.

The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Encore Humeral Shoulder Stem.

Pre-market Notification Details

Device IDK141990
510k NumberK141990
Device Name:ENCORE HUMERAL SHOULDER STEM
ClassificationShoulder Prosthesis, Reverse Configuration
Applicant ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin,  TX  78758
ContactTeffany Hutto
CorrespondentTeffany Hutto
ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin,  TX  78758
Product CodePHX  
Subsequent Product CodeHSD
Subsequent Product CodeKWS
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-07-22
Decision Date2014-11-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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