ACCIN UNI-KNEE SYSTEM

Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer

ACCIN CORPORATION

The following data is part of a premarket notification filed by Accin Corporation with the FDA for Accin Uni-knee System.

Pre-market Notification Details

Device IDK063782
510k NumberK063782
Device Name:ACCIN UNI-KNEE SYSTEM
ClassificationProsthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Applicant ACCIN CORPORATION 1033 US HIGHWAY 46 EAST SUITE A204 Clifton,  NJ  07013
ContactMichael Kvitnitsky
CorrespondentMichael Kvitnitsky
ACCIN CORPORATION 1033 US HIGHWAY 46 EAST SUITE A204 Clifton,  NJ  07013
Product CodeHSX  
CFR Regulation Number888.3520 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-12-21
Decision Date2007-01-19
Summary:summary

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