THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS

Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer

IMPLEX CORP.

The following data is part of a premarket notification filed by Implex Corp. with the FDA for The Nexgen Knee System Uncemented Components.

Pre-market Notification Details

Device IDK031462
510k NumberK031462
Device Name:THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS
ClassificationProsthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Applicant IMPLEX CORP. 80 COMMERCE DR. Allendale,  NJ  07401 -1600
ContactMarci Halevi
CorrespondentMarci Halevi
IMPLEX CORP. 80 COMMERCE DR. Allendale,  NJ  07401 -1600
Product CodeMBH  
CFR Regulation Number888.3565 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-05-08
Decision Date2003-08-06
Summary:summary

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