Plasma Coated NTK System 117.111P

GUDID 05055196910607

NTK TIBIA STD STEM

CORIN LTD

Coated knee tibia prosthesis

• Primary Device ID: 05055196910607
• NIH Device Record Key: ee9a9b0e-975e-4d22-aa20-9c8e636b79da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plasma Coated NTK System
• Version Model Number: 117.111P
• Catalog Number: 117.111P
• 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	05055196910607 [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

[05055196910607]

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

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• 05055343893975: NTK PEGGED FEMUR
• 05055343893968: NTK STEM FEMUR
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• 05055343893708: NTK STEM FEMUR
• 05055343893692: NTK STEM FEMUR
• 05055343893685: NTK STEM FEMUR
• 05055343893678: NTK STEM FEMUR
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• 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