SYNTHES (USA) EPOCA SHOULDER PROSTHESIS SYSTEM

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Epoca Shoulder Prosthesis System.

Pre-market Notification Details

Device IDK072578
510k NumberK072578
Device Name:SYNTHES (USA) EPOCA SHOULDER PROSTHESIS SYSTEM
ClassificationProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Applicant SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester,  PA  19380
ContactSheri Musgnung
CorrespondentSheri Musgnung
SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester,  PA  19380
Product CodeHSD  
Subsequent Product CodeKWT
Subsequent Product CodeMBF
CFR Regulation Number888.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-09-13
Decision Date2007-11-28
Summary:summary

NIH GUDID Devices

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