Escalade Legend Acetabular Shell

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

ORTHO DEVELOPMENT CORPORATION

The following data is part of a premarket notification filed by Ortho Development Corporation with the FDA for Escalade Legend Acetabular Shell.

Pre-market Notification Details

Device IDK161080
510k NumberK161080
Device Name:Escalade Legend Acetabular Shell
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant ORTHO DEVELOPMENT CORPORATION 12187 SOUTH BUSINESS PARK DRIVE Draper,  UT  84020
ContactDrew Weaver
CorrespondentDrew Weaver
ORTHO DEVELOPMENT CORPORATION 12187 SOUTH BUSINESS PARK DRIVE Draper,  UT  84020
Product CodeLPH  
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-04-18
Decision Date2016-05-17
Summary:summary

NIH GUDID Devices

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