LOSPA Modular Knee System

GUDID 08806373864926

LOSPA Stem Extension (Cemented)

Corentec Co., Ltd

Knee femur stem prosthesis
Primary Device ID08806373864926
NIH Device Record Keye8d84698-6ae7-4aa7-b236-ab6e9d33fbc4
Commercial Distribution StatusIn Commercial Distribution
Brand NameLOSPA Modular Knee System
Version Model NumberK2.C16.0030
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

Device Identifiers

Device Issuing AgencyDevice ID
GS108806373864926 [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 Date2020-04-20
Device Publish Date2017-01-25

On-Brand Devices [LOSPA Modular Knee System]

08806373860591LOSPA Modular Femoral Component (PS type) (Right)
08806373860577LOSPA Modular Femoral Component (PS type) (Right)
08806373860560LOSPA Modular Femoral Component (PS type) (Right)
08806373860553LOSPA Modular Femoral Component (PS type) (Right)
08806373860546LOSPA Modular Femoral Component (PS type) (Right)
08806373860522LOSPA Modular Femoral Component (PS type) (Right)
08806373860515LOSPA Modular Femoral Component (PS type) (Right)
08806373860508LOSPA Modular Femoral Component (PS type) (Right)
08806373860492LOSPA Modular Femoral Component (PS type) (Right)
08806373860485LOSPA Modular Femoral Component (PS type) (Right)
08806373860478LOSPA Modular Femoral Component (PS type) (Right)
08806373860461LOSPA Modular Femoral Component (PS type) (Right)
08806373860447LOSPA Modular Femoral Component (PS type) (Right)
08806373860430LOSPA Modular Femoral Component (PS type) (Left)
08806373860416LOSPA Modular Femoral Component (PS type) (Left)
08806373860409LOSPA Modular Femoral Component (PS type) (Left)
08806373860393LOSPA Modular Femoral Component (PS type) (Left)
08806373860386LOSPA Modular Femoral Component (PS type) (Left)
08806373860362LOSPA Modular Femoral Component (PS type) (Left)
08806373860355LOSPA Modular Femoral Component (PS type) (Left)
08806373860348LOSPA Modular Femoral Component (PS type) (Left)
08806373860331LOSPA Modular Femoral Component (PS type) (Left)
08806373860324LOSPA Modular Femoral Component (PS type) (Left)
08806373860317LOSPA Modular Femoral Component (PS type) (Left)
08806373860300LOSPA Modular Femoral Component (PS type) (Left)
08806373860287LOSPA Modular Femoral Component (PS type) (Left)
08806373867866LOSPA Stem Extension (Cemented)
08806373867859LOSPA Stem Extension (Cemented)
08806373867842LOSPA Stem Extension (Cemented)
08806373867835LOSPA Stem Extension (Cemented)
08806373867828LOSPA Stem Extension (Cemented)
08806373867811LOSPA Stem Extension (Cemented)
08806373867804LOSPA Stem Extension (Cemented)
08806373867798LOSPA Stem Extension (Cemented)
08806373867781LOSPA Stem Extension (Cemented)
08806373867774LOSPA Stem Extension (Cemented)
08806373867767LOSPA Stem Extension (Cemented)
08806373867750LOSPA Stem Extension (Cemented)
08806373867743LOSPA Stem Extension (Cemented)
08806373867736LOSPA Stem Extension (Cemented)
08806373867729LOSPA Stem Extension (Cemented)
08806373867712LOSPA Stem Extension (Cemented)
08806373867705LOSPA Stem Extension (Cemented)
08806373867699LOSPA Stem Extension (Cemented)
08806373867682LOSPA Stem Extension (Cemented)
08806373867675LOSPA Stem Extension (Cemented)
08806373867668LOSPA Stem Extension (Cemented)
08806373865718LOSPA Stem Extension (Cemented)
08806373865701LOSPA Stem Extension (Cemented)
08806373865695LOSPA Stem Extension (Cemented)

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