LOSPA Modular Knee System

GUDID 08800068965219

Modular Femoral Component Trial #04 L

Corentec Co., Ltd

Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable

• Primary Device ID: 08800068965219
• NIH Device Record Key: 67ed360c-f228-4193-950d-853b26d4cfdc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LOSPA Modular Knee System
• Version Model Number: KB.SFT.E04LB
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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: +82415857114
• Email: sungwon.yang@corentec.com
• Phone: +82415857114
• Email: sungwon.yang@corentec.com
• Phone: +82415857114
• Email: sungwon.yang@corentec.com
• Phone: +82415857114
• Email: sungwon.yang@corentec.com
• Phone: +82415857114
• Email: sungwon.yang@corentec.com
• Phone: +82415857114
• Email: sungwon.yang@corentec.com
• Phone: +82415857114
• Email: sungwon.yang@corentec.com
• Phone: +82415857114
• Email: sungwon.yang@corentec.com
• Phone: +82415857114
• Email: sungwon.yang@corentec.com
• Phone: +82415857114
• Email: sungwon.yang@corentec.com
• Phone: +82415857114
• Email: sungwon.yang@corentec.com
• Phone: +82415857114
• Email: sungwon.yang@corentec.com
• Phone: +82415857114
• Email: sungwon.yang@corentec.com
• Phone: +82415857114
• Email: sungwon.yang@corentec.com
• Phone: +82415857114
• Email: sungwon.yang@corentec.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800068965219 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222278

FDA Product Code

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

Sterilization

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

[08800068965219]

Moist Heat or Steam Sterilization

[08800068965219]

Moist Heat or Steam Sterilization

[08800068965219]

Moist Heat or Steam Sterilization

[08800068965219]

Moist Heat or Steam Sterilization

[08800068965219]

Moist Heat or Steam Sterilization

[08800068965219]

Moist Heat or Steam Sterilization

[08800068965219]

Moist Heat or Steam Sterilization

[08800068965219]

Moist Heat or Steam Sterilization

[08800068965219]

Moist Heat or Steam Sterilization

[08800068965219]

Moist Heat or Steam Sterilization

[08800068965219]

Moist Heat or Steam Sterilization

[08800068965219]

Moist Heat or Steam Sterilization

[08800068965219]

Moist Heat or Steam Sterilization

[08800068965219]

Moist Heat or Steam Sterilization

[08800068965219]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-31
• Device Publish Date: 2022-10-23

On-Brand Devices [LOSPA Modular Knee System ]

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