LOSPA Knee System

GUDID 08806373883576

Tibial insert trial-Fixed-CR-SZ 7-16T

Corentec Co., Ltd

Knee tibia prosthesis trial, reusable

• Primary Device ID: 08806373883576
• NIH Device Record Key: c2a7f850-f532-4f13-97d8-76b3b2af8299
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LOSPA Knee System
• Version Model Number: 01.62.178
• 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: +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
• 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	08806373883576 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110404

FDA Product Code

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

Sterilization

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

[08806373883576]

Moist Heat or Steam Sterilization

[08806373883576]

Moist Heat or Steam Sterilization

[08806373883576]

Moist Heat or Steam Sterilization

[08806373883576]

Moist Heat or Steam Sterilization

[08806373883576]

Moist Heat or Steam Sterilization

[08806373883576]

Moist Heat or Steam Sterilization

[08806373883576]

Moist Heat or Steam Sterilization

[08806373883576]

Moist Heat or Steam Sterilization

[08806373883576]

Moist Heat or Steam Sterilization

[08806373883576]

Moist Heat or Steam Sterilization

[08806373883576]

Moist Heat or Steam Sterilization

[08806373883576]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2022-03-22
• Device Publish Date: 2018-01-31

On-Brand Devices [LOSPA Knee System]

• 08806373890086: Pin driver
• 08806373890062: Pin holder
• 08806373889813: Tibial reamer
• 08806373878138: Reamer Φ18
• 08806373878121: Reamer Φ17
• 08806373878114: Reamer Φ16
• 08806373878107: Reamer Φ15
• 08806373878091: Reamer Φ14
• 08806373878084: Reamer Φ13
• 08806373878077: Reamer Φ12
• 08806373878060: Reamer Φ11
• 08806373878053: Reamer Φ10
• 08806373878046: Reamer Φ09
• 08806373875311: Offset Reamer ∅18
• 08806373875304: Offset Reamer ∅17
• 08806373875298: Offset Reamer ∅16
• 08806373875281: Offset Reamer ∅15
• 08806373875274: Offset Reamer ∅14
• 08806373875267: Offset Reamer ∅13
• 08806373875250: Offset Reamer ∅12
• 08806373875243: Offset Reamer ∅11
• 08806373875236: Offset Reamer ∅10
• 08806373875229: Offset Reamer ∅9
• 08806373898570: Tibial baseplate trial-Fixed-SZ 16
• 08806373898563: Tibial baseplate trial-Fixed-SZ 14
• 08806373898556: Tibial baseplate trial-Fixed-SZ 12
• 08806373898549: Tibial baseplate trial-Fixed-SZ 6
• 08806373898532: Tibial insert trial-Fixed-PS-SZ 16-26T
• 08806373898525: Tibial insert trial-Fixed-PS-SZ 16-24T
• 08806373898518: Tibial insert trial-Fixed-PS-SZ 16-22T
• 08806373898501: Tibial insert trial-Fixed-PS-SZ 16-20T
• 08806373898495: Tibial insert trial-Fixed-PS-SZ 16-18T
• 08806373898488: Tibial insert trial-Fixed-PS-SZ 16-16T
• 08806373898471: Tibial insert trial-Fixed-PS-SZ 16-14T
• 08806373898464: Tibial insert trial-Fixed-PS-SZ 16-12T
• 08806373898457: Tibial insert trial-Fixed-PS-SZ 16-10T
• 08806373898440: Tibial insert trial-Fixed-PS-SZ 16-8T
• 08806373898433: Tibial insert trial-Fixed-PS-SZ 14-26T
• 08806373898426: Tibial insert trial-Fixed-PS-SZ 14-24T
• 08806373898419: Tibial insert trial-Fixed-PS-SZ 14-22T
• 08806373898402: Tibial insert trial-Fixed-PS-SZ 14-20T
• 08806373898396: Tibial insert trial-Fixed-PS-SZ 14-18T
• 08806373898389: Tibial insert trial-Fixed-PS-SZ 14-16T
• 08806373898372: Tibial insert trial-Fixed-PS-SZ 14-14T
• 08806373898365: Tibial insert trial-Fixed-PS-SZ 14-12T
• 08806373898358: Tibial insert trial-Fixed-PS-SZ 14-10T
• 08806373898341: Tibial insert trial-Fixed-PS-SZ 14-8T
• 08806373898334: Tibial insert trial-Fixed-PS-SZ 12-26T
• 08806373898327: Tibial insert trial-Fixed-PS-SZ 12-24T
• 08806373898310: Tibial insert trial-Fixed-PS-SZ 12-22T