LOSPA Total Knee System

GUDID 08806373853722

LOSPA Patellar Component (Dome)

Corentec Co., Ltd

Polyethylene patella prosthesis
Primary Device ID08806373853722
NIH Device Record Key583ed018-cc24-4243-8cb1-7bc2289c98c4
Commercial Distribution StatusIn Commercial Distribution
Brand NameLOSPA Total Knee System
Version Model Number01.10.98A
Company DUNS688739895
Company NameCorentec Co., Ltd
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+820415857114
Emailhckoh@corentec.com
Phone+820415857114
Emailhckoh@corentec.com
Phone+820415857114
Emailhckoh@corentec.com
Phone+820415857114
Emailhckoh@corentec.com
Phone+820415857114
Emailhckoh@corentec.com
Phone+820415857114
Emailhckoh@corentec.com
Phone+820415857114
Emailhckoh@corentec.com
Phone+820415857114
Emailhckoh@corentec.com
Phone+820415857114
Emailhckoh@corentec.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108806373853722 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-02-05
Device Publish Date2015-10-07

On-Brand Devices [LOSPA Total Knee System]

08806373868566LOSPA Femoral Component (PS)(Right)
08806373868559LOSPA Femoral Component (PS)(Left)
08806373868542LOSPA Femoral Component (CR)(Right)
08806373868535LOSPA Femoral Component (CR)(Left)
08806373853548LOSPA Femoral Component (CR)(Left)
08806373853531LOSPA Femoral Component (CR)(Right)
08806373852992LOSPA Femoral Component (PS)(Right)
08806373852985LOSPA Femoral Component (PS)(Left)
08806373820632LOSPA Femoral Component (PS)(Right)
08806373820625LOSPA Femoral Component (PS)(Right)
08806373820618LOSPA Femoral Component (PS)(Right)
08806373820595LOSPA Femoral Component (PS)(Right)
08806373820588LOSPA Femoral Component (PS)(Right)
08806373820571LOSPA Femoral Component (PS)(Right)
08806373820564LOSPA Femoral Component (PS)(Right)
08806373820557LOSPA Femoral Component (PS)(Right)
08806373820540LOSPA Femoral Component (PS)(Right)
08806373820533LOSPA Femoral Component (PS)(Right)
08806373820519LOSPA Femoral Component (PS)(Right)
08806373820502LOSPA Femoral Component (PS)(Left)
08806373820496LOSPA Femoral Component (PS)(Left)
08806373820489LOSPA Femoral Component (PS)(Left)
08806373820465LOSPA Femoral Component (PS)(Left)
08806373820458LOSPA Femoral Component (PS)(Left)
08806373820441LOSPA Femoral Component (PS)(Left)
08806373820434LOSPA Femoral Component (PS)(Left)
08806373820427LOSPA Femoral Component (PS)(Left)
08806373820410LOSPA Femoral Component (PS)(Left)
08806373820403LOSPA Femoral Component (PS)(Left)
08806373820380LOSPA Femoral Component (PS)(Left)
08806373820373LOSPA Femoral Component (CR)(Right)
08806373820366LOSPA Femoral Component (CR)(Right)
08806373820359LOSPA Femoral Component (CR)(Right)
08806373820335LOSPA Femoral Component (CR)(Right)
08806373820328LOSPA Femoral Component (CR)(Right)
08806373820311LOSPA Femoral Component (CR)(Right)
08806373820304LOSPA Femoral Component (CR)(Right)
08806373820298LOSPA Femoral Component (CR)(Right)
08806373820281LOSPA Femoral Component (CR)(Right)
08806373820274LOSPA Femoral Component (CR)(Right)
08806373820250LOSPA Femoral Component (CR)(Right)
08806373820243LOSPA Femoral Component (CR)(Left)
08806373820236LOSPA Femoral Component (CR)(Left)
08806373820229LOSPA Femoral Component (CR)(Left)
08806373820205LOSPA Femoral Component (CR)(Left)
08806373820199LOSPA Femoral Component (CR)(Left)
08806373820182LOSPA Femoral Component (CR)(Left)
08806373820175LOSPA Femoral Component (CR)(Left)
08806373820168LOSPA Femoral Component (CR)(Left)
08806373820151LOSPA Femoral Component (CR)(Left)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.