APEX MODULAR ACETABULAR CUP

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

APEX SURGICAL, LLC.

The following data is part of a premarket notification filed by Apex Surgical, Llc. with the FDA for Apex Modular Acetabular Cup.

Pre-market Notification Details

Device IDK031110
510k NumberK031110
Device Name:APEX MODULAR ACETABULAR CUP
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant APEX SURGICAL, LLC. 12 HARDING STREET,SUITE 202 Lakeville,  MA  02347
ContactEdward J Cheal
CorrespondentEdward J Cheal
APEX SURGICAL, LLC. 12 HARDING STREET,SUITE 202 Lakeville,  MA  02347
Product CodeLPH  
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-04-08
Decision Date2003-05-22
Summary:summary

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