EXULT Knee Replacement System

GUDID 08800017264202

Tibial insert-Fixed-PS-XLPE-11-12T

Corentec Co., Ltd

Knee tibia prosthesis trial

• Primary Device ID: 08800017264202
• NIH Device Record Key: df1d5337-96d6-452f-b286-447ddb85af55
• Commercial Distribution Discontinuation: 2020-01-10
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: EXULT Knee Replacement System
• Version Model Number: K3.IBX.5786-12T
• Company DUNS: 688739895
• Company Name: Corentec Co., Ltd
• Device Count: 1
• DM Exempt: false
• 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: +82414107176
• Email: sungwon.yang@corentec.com
• Phone: +82414107176
• Email: sungwon.yang@corentec.com
• Phone: +82414107176
• Email: sungwon.yang@corentec.com
• Phone: +82414107176
• Email: sungwon.yang@corentec.com
• Phone: +82414107176
• Email: sungwon.yang@corentec.com
• Phone: +82414107176
• Email: sungwon.yang@corentec.com
• Phone: +82414107176
• Email: sungwon.yang@corentec.com
• Phone: +82414107176
• Email: sungwon.yang@corentec.com
• Phone: +82414107176
• Email: sungwon.yang@corentec.com
• Phone: +82414107176
• Email: sungwon.yang@corentec.com
• Phone: +82414107176
• Email: sungwon.yang@corentec.com
• Phone: +82414107176
• Email: sungwon.yang@corentec.com
• Phone: +82414107176
• Email: sungwon.yang@corentec.com
• Phone: +82414107176
• Email: sungwon.yang@corentec.com
• Phone: +82414107176
• Email: sungwon.yang@corentec.com
• Phone: +82414107176
• Email: sungwon.yang@corentec.com
• Phone: +82414107176
• Email: sungwon.yang@corentec.com
• Phone: +82414107176
• Email: sungwon.yang@corentec.com
• Phone: +82414107176
• Email: sungwon.yang@corentec.com
• Phone: +82414107176
• Email: sungwon.yang@corentec.com
• Phone: +82414107176
• Email: sungwon.yang@corentec.com
• Phone: +82414107176
• Email: sungwon.yang@corentec.com
• Phone: +82414107176
• Email: sungwon.yang@corentec.com
• Phone: +82414107176
• Email: sungwon.yang@corentec.com
• Phone: +82414107176
• Email: sungwon.yang@corentec.com
• Phone: +82414107176
• Email: sungwon.yang@corentec.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800017264202 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192507

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-20
• Device Publish Date: 2020-01-10

On-Brand Devices [EXULT Knee Replacement System]

• 08800017294872: Tibial Insert Trial CR #08 T18
• 08800017294865: Tibial Insert Trial CR #08 T16
• 08800017294858: Tibial Insert Trial CR #08 T14
• 08800017294841: Tibial Insert Trial CR #08 T13
• 08800017294834: Tibial Insert Trial CR #08 T12
• 08800017294827: Tibial Insert Trial CR #08 T11
• 08800017294810: Tibial Insert Trial CR #08 T10
• 08800017294803: Tibial Insert Trial CR #08 T09
• 08800017294797: Tibial Insert Trial CR #07 T24
• 08800017294780: Tibial Insert Trial CR #07 T22
• 08800017294773: Tibial Insert Trial CR #07 T20
• 08800017294766: Tibial Insert Trial CR #07 T18
• 08800017294759: Tibial Insert Trial CR #07 T16
• 08800017294742: Tibial Insert Trial CR #07 T14
• 08800017294735: Tibial Insert Trial CR #07 T13
• 08800017294728: Tibial Insert Trial CR #07 T12
• 08800017294711: Tibial Insert Trial CR #07 T11
• 08800017294704: Tibial Insert Trial CR #07 T10
• 08800017294698: Tibial Insert Trial CR #07 T09
• 08800017294681: Tibial Insert Trial CR #06 T24
• 08800017294674: Tibial Insert Trial CR #06 T22
• 08800017294667: Tibial Insert Trial CR #06 T20
• 08800017294650: Tibial Insert Trial CR #06 T18
• 08800017294643: Tibial Insert Trial CR #06 T16
• 08800017294636: Tibial Insert Trial CR #06 T14
• 08800017294629: Tibial Insert Trial CR #06 T13
• 08800017294612: Tibial Insert Trial CR #06 T12
• 08800017294605: Tibial Insert Trial CR #06 T11
• 08800017294599: Tibial Insert Trial CR #06 T10
• 08800017294582: Tibial Insert Trial CR #06 T09
• 08800017294575: Tibial Insert Trial CR #05 T24
• 08800017294568: Tibial Insert Trial CR #05 T22
• 08800017294551: Tibial Insert Trial CR #05 T20
• 08800017294544: Tibial Insert Trial CR #05 T18
• 08800017294537: Tibial Insert Trial CR #05 T16
• 08800017294520: Tibial Insert Trial CR #05 T14
• 08800017294513: Tibial Insert Trial CR #05 T13
• 08800017294506: Tibial Insert Trial CR #05 T12
• 08800017294490: Tibial Insert Trial CR #05 T11
• 08800017294483: Tibial Insert Trial CR #05 T10
• 08800017294476: Tibial Insert Trial CR #05 T09
• 08800017294469: Tibial Insert Trial CR #04 T24
• 08800017294452: Tibial Insert Trial CR #04 T22
• 08800017294445: Tibial Insert Trial CR #04 T20
• 08800017294438: Tibial Insert Trial CR #04 T18
• 08800017294421: Tibial Insert Trial CR #04 T16
• 08800017294414: Tibial Insert Trial CR #04 T14
• 08800017294407: Tibial Insert Trial CR #04 T13
• 08800017294391: Tibial Insert Trial CR #04 T12
• 08800017294384: Tibial Insert Trial CR #04 T11