LOSPA Knee System

GUDID 08800017284569

Box notch impactor

Corentec Co., Ltd

Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable

• Primary Device ID: 08800017284569
• NIH Device Record Key: 698bc0dd-0204-443d-8132-25980654e81f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LOSPA Knee System
• Version Model Number: KZ.017.0129
• Company DUNS: 688739895
• Company Name: Corentec Co., Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: +820269374902
• Email: ra@corentec.com
• Phone: +820269374902
• Email: ra@corentec.com
• Phone: +820269374902
• Email: ra@corentec.com
• Phone: +820269374902
• Email: ra@corentec.com
• Phone: +820269374902
• Email: ra@corentec.com
• Phone: +820269374902
• Email: ra@corentec.com
• Phone: +820269374902
• Email: ra@corentec.com
• Phone: +820269374902
• Email: ra@corentec.com
• Phone: +820269374902
• Email: ra@corentec.com
• Phone: +820269374902
• Email: ra@corentec.com
• Phone: +820269374902
• Email: ra@corentec.com
• Phone: +820269374902
• Email: ra@corentec.com
• Phone: +820269374902
• Email: ra@corentec.com
• Phone: +820269374902
• Email: ra@corentec.com
• Phone: +820269374902
• Email: ra@corentec.com
• Phone: +820269374902
• Email: ra@corentec.com
• Phone: +820269374902
• Email: ra@corentec.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800017284569 [Primary]

FDA Product Code

• HWA: Impactor

Sterilization

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

[08800017284569]

Moist Heat or Steam Sterilization

[08800017284569]

Moist Heat or Steam Sterilization

[08800017284569]

Moist Heat or Steam Sterilization

[08800017284569]

Moist Heat or Steam Sterilization

[08800017284569]

Moist Heat or Steam Sterilization

[08800017284569]

Moist Heat or Steam Sterilization

[08800017284569]

Moist Heat or Steam Sterilization

[08800017284569]

Moist Heat or Steam Sterilization

[08800017284569]

Moist Heat or Steam Sterilization

[08800017284569]

Moist Heat or Steam Sterilization

[08800017284569]

Moist Heat or Steam Sterilization

[08800017284569]

Moist Heat or Steam Sterilization

[08800017284569]

Moist Heat or Steam Sterilization

[08800017284569]

Moist Heat or Steam Sterilization

[08800017284569]

Moist Heat or Steam Sterilization

[08800017284569]

Moist Heat or Steam Sterilization

[08800017284569]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-22
• Device Publish Date: 2024-01-12

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