ACS LD Uni FB Knee System

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

Implantcast GmbH

The following data is part of a premarket notification filed by Implantcast Gmbh with the FDA for Acs Ld Uni Fb Knee System.

Pre-market Notification Details

Device IDK203341
510k NumberK203341
Device Name:ACS LD Uni FB Knee System
ClassificationProsthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Applicant Implantcast GmbH Lueneburger Schanze 26 Buxtehude,  DE 21614
ContactJuliane Hoeppner
CorrespondentDave Mcgurl
MCRA, LLC 1050 K Street NW Suite 1000 Washington,  DC  20001
Product CodeHSX  
CFR Regulation Number888.3520 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-12
Decision Date2021-01-08

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.