ASK System

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

L And K Biomed Corporation Limited

The following data is part of a premarket notification filed by L And K Biomed Corporation Limited with the FDA for Ask System.

Pre-market Notification Details

Device IDK181146
510k NumberK181146
Device Name:ASK System
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant L And K Biomed Corporation Limited 18f, 159-1, Mokdongseo-ro Yangcheon-gu,  KR 07997
ContactSemi Jang
CorrespondentSemi Jang
L And K Biomed Corporation Limited 18f, 159-1, Mokdongseo-ro Yangcheon-gu,  KR 07997
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-05-01
Decision Date2018-08-03
Summary:summary

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