Plasma Coated NTK System 117.119P

GUDID 05055196910645

NTK TIBIA STD STEM

CORIN LTD

Coated knee tibia prosthesis

• Primary Device ID: 05055196910645
• NIH Device Record Key: e2380b02-687f-49fa-b1d3-c97e95d10672
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plasma Coated NTK System
• Version Model Number: 117.119P
• Catalog Number: 117.119P
• Company DUNS: 295437313
• Company Name: CORIN LTD
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +441285659866
• Email: lucinda.gerber@coringroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055196910645 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980545

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[05055196910645]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-17

On-Brand Devices [Plasma Coated NTK System]

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