LOSPA Total Knee System

GUDID 08806373853814

LOSPA Patellar Component (Dome)

Corentec Co., Ltd

Polyethylene patella prosthesis

• Primary Device ID: 08806373853814
• NIH Device Record Key: f9b4989b-3d7e-43f8-ae53-94ad3421c795
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LOSPA Total Knee System
• Version Model Number: 01.10.9EA
• 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
• Phone: +820415857114
• Email: hckoh@corentec.com
• Phone: +820415857114
• Email: hckoh@corentec.com
• Phone: +820415857114
• Email: hckoh@corentec.com
• Phone: +820415857114
• Email: hckoh@corentec.com
• Phone: +820415857114
• Email: hckoh@corentec.com
• Phone: +820415857114
• Email: hckoh@corentec.com
• Phone: +820415857114
• Email: hckoh@corentec.com
• Phone: +820415857114
• Email: hckoh@corentec.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806373853814 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130673

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: 2021-02-05
• Device Publish Date: 2015-10-07

On-Brand Devices [LOSPA Total Knee System]

• 08806373868566: LOSPA Femoral Component (PS)(Right)
• 08806373868559: LOSPA Femoral Component (PS)(Left)
• 08806373868542: LOSPA Femoral Component (CR)(Right)
• 08806373868535: LOSPA Femoral Component (CR)(Left)
• 08806373853548: LOSPA Femoral Component (CR)(Left)
• 08806373853531: LOSPA Femoral Component (CR)(Right)
• 08806373852992: LOSPA Femoral Component (PS)(Right)
• 08806373852985: LOSPA Femoral Component (PS)(Left)
• 08806373820632: LOSPA Femoral Component (PS)(Right)
• 08806373820625: LOSPA Femoral Component (PS)(Right)
• 08806373820618: LOSPA Femoral Component (PS)(Right)
• 08806373820595: LOSPA Femoral Component (PS)(Right)
• 08806373820588: LOSPA Femoral Component (PS)(Right)
• 08806373820571: LOSPA Femoral Component (PS)(Right)
• 08806373820564: LOSPA Femoral Component (PS)(Right)
• 08806373820557: LOSPA Femoral Component (PS)(Right)
• 08806373820540: LOSPA Femoral Component (PS)(Right)
• 08806373820533: LOSPA Femoral Component (PS)(Right)
• 08806373820519: LOSPA Femoral Component (PS)(Right)
• 08806373820502: LOSPA Femoral Component (PS)(Left)
• 08806373820496: LOSPA Femoral Component (PS)(Left)
• 08806373820489: LOSPA Femoral Component (PS)(Left)
• 08806373820465: LOSPA Femoral Component (PS)(Left)
• 08806373820458: LOSPA Femoral Component (PS)(Left)
• 08806373820441: LOSPA Femoral Component (PS)(Left)
• 08806373820434: LOSPA Femoral Component (PS)(Left)
• 08806373820427: LOSPA Femoral Component (PS)(Left)
• 08806373820410: LOSPA Femoral Component (PS)(Left)
• 08806373820403: LOSPA Femoral Component (PS)(Left)
• 08806373820380: LOSPA Femoral Component (PS)(Left)
• 08806373820373: LOSPA Femoral Component (CR)(Right)
• 08806373820366: LOSPA Femoral Component (CR)(Right)
• 08806373820359: LOSPA Femoral Component (CR)(Right)
• 08806373820335: LOSPA Femoral Component (CR)(Right)
• 08806373820328: LOSPA Femoral Component (CR)(Right)
• 08806373820311: LOSPA Femoral Component (CR)(Right)
• 08806373820304: LOSPA Femoral Component (CR)(Right)
• 08806373820298: LOSPA Femoral Component (CR)(Right)
• 08806373820281: LOSPA Femoral Component (CR)(Right)
• 08806373820274: LOSPA Femoral Component (CR)(Right)
• 08806373820250: LOSPA Femoral Component (CR)(Right)
• 08806373820243: LOSPA Femoral Component (CR)(Left)
• 08806373820236: LOSPA Femoral Component (CR)(Left)
• 08806373820229: LOSPA Femoral Component (CR)(Left)
• 08806373820205: LOSPA Femoral Component (CR)(Left)
• 08806373820199: LOSPA Femoral Component (CR)(Left)
• 08806373820182: LOSPA Femoral Component (CR)(Left)
• 08806373820175: LOSPA Femoral Component (CR)(Left)
• 08806373820168: LOSPA Femoral Component (CR)(Left)
• 08806373820151: LOSPA Femoral Component (CR)(Left)