OMNI ARC MONOBLOCK HIP STEM

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

OMNILIFE SCIENCE

The following data is part of a premarket notification filed by Omnilife Science with the FDA for Omni Arc Monoblock Hip Stem.

Pre-market Notification Details

Device IDK133381
510k NumberK133381
Device Name:OMNI ARC MONOBLOCK HIP STEM
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant OMNILIFE SCIENCE 10 O'CONNELL WAY, STE 10 East Taunton,  MA  02718
ContactChristina Flores
CorrespondentChristina Flores
OMNILIFE SCIENCE 10 O'CONNELL WAY, STE 10 East Taunton,  MA  02718
Product CodeLZO  
Subsequent Product CodeKWY
Subsequent Product CodeLPH
Subsequent Product CodeMEH
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-11-04
Decision Date2014-03-13
Summary:summary

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