LOSPA Total Knee System

GUDID 08806373853692

LOSPA Patellar Component (Dome)

Corentec Co., Ltd

Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis

• Primary Device ID: 08806373853692
• NIH Device Record Key: 15a9b860-5313-4b8e-9c78-08773d894baf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LOSPA Total Knee System
• Version Model Number: 01.10.9EC
• 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	08806373853692 [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)