Excia Total Hip System

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

AESCULAP IMPLANT SYSTEMS, LLC

The following data is part of a premarket notification filed by Aesculap Implant Systems, Llc with the FDA for Excia Total Hip System.

Pre-market Notification Details

Device IDK150062
510k NumberK150062
Device Name:Excia Total Hip System
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant AESCULAP IMPLANT SYSTEMS, LLC 3773 CORPORATE PARKWAY Center Valley,  PA  18034
ContactJulie Tom Wing
CorrespondentJulie Tom Wing
AESCULAP IMPLANT SYSTEMS, LLC 3773 CORPORATE PARKWAY Center Valley,  PA  18034
Product CodeLZO  
Subsequent Product CodeKWY
Subsequent Product CodeLWJ
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-01-13
Decision Date2015-02-09
Summary:summary

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