Apex Knee System

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

OMNIlife Science

The following data is part of a premarket notification filed by Omnilife Science with the FDA for Apex Knee System.

Pre-market Notification Details

Device IDK201611
510k NumberK201611
Device Name:Apex Knee System
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant OMNIlife Science 480 Paramount Drive Raynham,  MA  02767
ContactDipti Dharia
CorrespondentDipti Dharia
OMNIlife Science 480 Paramount Drive Raynham,  MA  02767
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-15
Decision Date2021-04-02

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