LOSPA Modular Knee System

GUDID 08806373864537

LOSPA Stem Extension (Cemented)

Corentec Co., Ltd

Knee femur stem prosthesis

• Primary Device ID: 08806373864537
• NIH Device Record Key: 746a9c54-d4f3-4f8a-90e5-cded01d2c973
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LOSPA Modular Knee System
• Version Model Number: K2.C13.0120
• 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: +820415857114
• Email: hckoh@corentec.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806373864537 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160157

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-04-20
• Device Publish Date: 2017-01-25

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)