APEX MODULAR ALUMINA FEMORAL HEAD

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-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 Alumina Femoral Head.

Pre-market Notification Details

Device IDK012918
510k NumberK012918
Device Name:APEX MODULAR ALUMINA FEMORAL HEAD
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-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 CodeLZO  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-08-30
Decision Date2001-11-27
Summary:summary

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