APEX HCLA ACETABULAR CUP LINERS

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

OMNILIFE SCIENCE

The following data is part of a premarket notification filed by Omnilife Science with the FDA for Apex Hcla Acetabular Cup Liners.

Pre-market Notification Details

Device IDK062489
510k NumberK062489
Device Name:APEX HCLA ACETABULAR CUP LINERS
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant OMNILIFE SCIENCE 175 PARAMOUNT DR SUITE 302 Raynham,  MA  02767
ContactEdward Cheal
CorrespondentEdward Cheal
OMNILIFE SCIENCE 175 PARAMOUNT DR SUITE 302 Raynham,  MA  02767
Product CodeLPH  
Subsequent Product CodeLZO
Subsequent Product CodeMEH
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-08-25
Decision Date2007-08-15
Summary:summary

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