MENDEC SPINE HV

GUDID 08031497003313

Mendec Spine HV is a highly viscous radiopaque acrylic resin (PMMA based) indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty or kyphoplasty procedure. The device is disposable and sterile.

TECRES SPA

Orthopaedic cement preparation/delivery kit

• Primary Device ID: 08031497003313
• NIH Device Record Key: cca1de2f-77ae-4f59-a997-0e722c085223
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MENDEC SPINE HV
• Version Model Number: 12C20H1
• Company DUNS: 435428396
• Company Name: TECRES SPA
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08031497003313 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122175

FDA Product Code

• NDN: Cement, Bone, Vertebroplasty

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: 2023-06-09
• Device Publish Date: 2023-06-01

Devices Manufactured by TECRES SPA

• 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,