ACCIN HIP SYSTEM

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

ACCELERATED INNOVATION, LLC

The following data is part of a premarket notification filed by Accelerated Innovation, Llc with the FDA for Accin Hip System.

Pre-market Notification Details

Device IDK073068
510k NumberK073068
Device Name:ACCIN HIP SYSTEM
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant ACCELERATED INNOVATION, LLC 1033 US HIGHWAY 46 EAST SUITE A204 Clifton,  NJ  07013
ContactMichael Kvitnitsky
CorrespondentMichael Kvitnitsky
ACCELERATED INNOVATION, LLC 1033 US HIGHWAY 46 EAST SUITE A204 Clifton,  NJ  07013
Product CodeLPH  
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-10-30
Decision Date2008-01-10
Summary:summary

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