Mendec® Kypho Set Monolateral 10 mm

GUDID 08031497003689

The Mendec Kypho Set consists of a combination of devices (Kyphoplasty Balloons, Kyphoplasty Tool Kits, Balloon Inflator) intended to provide the end user with either a monolateral or bilateral configuration for use in kyphoplasty procedures.

TECRES SPA

Orthopaedic cement preparation/delivery kit

• Primary Device ID: 08031497003689
• NIH Device Record Key: 15ad3f7e-6119-4a44-87f3-c942788daf2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mendec® Kypho Set Monolateral 10 mm
• Version Model Number: ASB030A
• Company DUNS: 435428396
• Company Name: TECRES SPA
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08031497003689 [Primary]

FDA Product Code

• HRX: Arthroscope

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-25
• Device Publish Date: 2025-12-17

Devices Manufactured by TECRES SPA

• 08031497003689 - Mendec® Kypho Set Monolateral 10 mm: 2025-12-25The Mendec Kypho Set consists of a combination of devices (Kyphoplasty Balloons, Kyphoplasty Tool Kits, Balloon Inflator) intended to provide the end user with either a monolateral or bilateral configuration for use in kyphoplasty procedures.
• 08031497003689 - Mendec® Kypho Set Monolateral 10 mm: 2025-12-25 The Mendec Kypho Set consists of a combination of devices (Kyphoplasty Balloons, Kyphoplasty Tool Kits, Balloon Inflator) intend
• 08031497003696 - Mendec® Kypho Set Monolateral 15 mm: 2025-12-25 The Mendec Kypho Set consists of a combination of devices (Kyphoplasty Balloons, Kyphoplasty Tool Kits, Balloon Inflator) intend
• 08031497003702 - Mendec® Kypho Set Monolateral 20 mm: 2025-12-25 The Mendec Kypho Set consists of a combination of devices (Kyphoplasty Balloons, Kyphoplasty Tool Kits, Balloon Inflator) intend
• 08031497003801 - Mendec® Kypho Set Bilateral 10 mm: 2025-12-25 The Mendec Kypho Set consists of a combination of devices (Kyphoplasty Balloons, Kyphoplasty Tool Kits, Balloon Inflator) intend
• 08031497003818 - Mendec® Kypho Set Bilateral 15 mm: 2025-12-25 The Mendec Kypho Set consists of a combination of devices (Kyphoplasty Balloons, Kyphoplasty Tool Kits, Balloon Inflator) intend
• 08031497003825 - Mendec® Kypho Set Bilateral 20 mm: 2025-12-25 The Mendec Kypho Set consists of a combination of devices (Kyphoplasty Balloons, Kyphoplasty Tool Kits, Balloon Inflator) intend
• 08031497002057 - 2Mix Gun: 2024-02-20 2Mix Gun is designed to aid the extrusion of bone cement from 2Mix.
• 28031497001078 - 2Mix: 2024-02-20 2Mix is a medical device for mixing bone cement. The device includes several components: mixing container, mixing cap, cannula,