Plasma Coated NTK System 117.321P

GUDID 05055343893821

NTK STEM FEMUR

CORIN LTD

Coated knee femur prosthesis
Primary Device ID05055343893821
NIH Device Record Keyd27d7559-9cbf-4a05-834f-29eb9a28912f
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlasma Coated NTK System
Version Model Number117.321P
Catalog Number117.321P
Company DUNS295437313
Company NameCORIN LTD
Device Count1
DM Exempttrue
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+441285659866
Emaillucinda.gerber@coringroup.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105055343893821 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[05055343893821]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-17

On-Brand Devices [Plasma Coated NTK System]

05055343893999NTK TIBIA LONG STEM
05055343893982NTK PEGGED FEMUR
05055343893975NTK PEGGED FEMUR
05055343893968NTK STEM FEMUR
05055343893951NTK STEM FEMUR
05055343893944NTK STEM FEMUR
05055343893937NTK STEM FEMUR
05055343893920NTK STEM FEMUR
05055343893913NTK STEM FEMUR
05055343893906NTK STEM FEMUR
05055343893890NTK STEM FEMUR
05055343893883NTK STEM FEMUR
05055343893876NTK STEM FEMUR
05055343893869NTK STEM FEMUR
05055343893852NTK STEM FEMUR
05055343893845NTK STEM FEMUR
05055343893838NTK STEM FEMUR
05055343893821NTK STEM FEMUR
05055343893814NTK STEM FEMUR
05055343893807NTK STEM FEMUR
05055343893791NTK STEM FEMUR
05055343893784NTK STEM FEMUR
05055343893777NTK STEM FEMUR
05055343893760NTK STEM FEMUR
05055343893753NTK STEM FEMUR
05055343893746NTK STEM FEMUR
05055343893739NTK STEM FEMUR
05055343893722NTK STEM FEMUR
05055343893715NTK STEM FEMUR
05055343893708NTK STEM FEMUR
05055343893692NTK STEM FEMUR
05055343893685NTK STEM FEMUR
05055343893678NTK STEM FEMUR
05055343893661NTK STEM FEMUR
05055343893654NTK STEM FEMUR
05055343893647NTK STEM FEMUR
05055196946248NTK STEM FEMUR
05055196946231NTK STEM FEMUR
05055196946224NTK STEM FEMUR
05055196946217NTK STEM FEMUR
05055196946200NTK STEM FEMUR
05055196946132NTK PATELLA M/BACK A
05055196946125NTK TIBIA LONG STEM
05055196946118NTK TIBIA LONG STEM
05055196946101NTK TIBIA LONG STEM
05055196945937NTK STEM FEMUR
05055196945920NTK STEM FEMUR
05055196945913NTK STEM FEMUR
05055196945906NTK STEM FEMUR
05055196945890NTK STEM FEMUR

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