LOSPA Knee Surgical Instruments

GUDID 08806373875878

TIBIAL IMPLANT JIG HANDLE

Corentec Co., Ltd

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 08806373875878
• NIH Device Record Key: 96e2f05c-46b9-4135-bab5-d03d95c457b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LOSPA Knee Surgical Instruments
• Version Model Number: KB.ST0.0002-A1
• 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: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806373875878 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[08806373875878]

Moist Heat or Steam Sterilization

[08806373875878]

Moist Heat or Steam Sterilization

[08806373875878]

Moist Heat or Steam Sterilization

[08806373875878]

Moist Heat or Steam Sterilization

[08806373875878]

Moist Heat or Steam Sterilization

[08806373875878]

Moist Heat or Steam Sterilization

[08806373875878]

Moist Heat or Steam Sterilization

[08806373875878]

Moist Heat or Steam Sterilization

[08806373875878]

Moist Heat or Steam Sterilization

[08806373875878]

Moist Heat or Steam Sterilization

[08806373875878]

Moist Heat or Steam Sterilization

[08806373875878]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-16
• Device Publish Date: 2025-12-08

Devices Manufactured by Corentec Co., Ltd

• 08806373887703 - BENCOX Surgical Instruments: 2026-03-03 Ruler
• 08809945895021 - EXULT Surgical Instrument: 2026-03-02 Base, Size 2-4
• 08809945895038 - EXULT Surgical Instrument: 2026-03-02 Base, Size 5-8
• 08809945895045 - EXULT Surgical Instrument: 2026-03-02 Base, Size 9-11
• 08809945895052 - EXULT Surgical Instrument: 2026-03-02 Shim, 10mm
• 08809945895069 - EXULT Surgical Instrument: 2026-03-02 Shim, 11mm
• 08809945895083 - EXULT Surgical Instrument: 2026-03-02 Shim, 13mm
• 08809945895090 - EXULT Surgical Instrument: 2026-03-02 Shim, 14mm