Total Knee Arthroplasty System

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

Responsive Orthopedics LLC

The following data is part of a premarket notification filed by Responsive Orthopedics Llc with the FDA for Total Knee Arthroplasty System.

Pre-market Notification Details

Device IDK150496
510k NumberK150496
Device Name:Total Knee Arthroplasty System
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant Responsive Orthopedics LLC 1755 Concordia Street Wayzata,  MN  55391
ContactDoug Kohrs
CorrespondentJude Paganelli
Cor Medical Ventures LLC 101 N. Acacia Ave, Suite 106 Solana Beach,  CA  92075
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-02-25
Decision Date2015-06-12
Summary:summary

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