Mendec Spine HV System

GUDID 28031497001382

Mendec Spine HV System is indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty or kyphoplasty procedure.

TECRES SPA

Orthopaedic cement preparation/delivery kit

• Primary Device ID: 28031497001382
• NIH Device Record Key: 37b44f35-ab29-47ad-94f9-64b95881466d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mendec Spine HV System
• Version Model Number: 13C2040
• 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	28031497001382 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122175

FDA Product Code

• LOD: Bone Cement

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-06

Devices Manufactured by TECRES SPA

• 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,
• 08031497003351 - TEKTONA HV US Bone Cement: 2023-06-16 TEKTONA HV US Bone Cement is indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty
• 08031497003313 - MENDEC SPINE HV: 2023-06-09 Mendec Spine HV is a highly viscous radiopaque acrylic resin (PMMA based) indicated for the treatment of pathological fractures
• 08031497002842 - MectaCem BonePrep: 2022-11-25
• 08031497002859 - MectaCem Bowl: 2022-11-25
• 08031497000695 - BONE INJECTION NEEDLE diamond tip 9 Gauge 150 mm length: 2022-10-03 BONE INJECTION NEEDLE diamond tip 9 Gauge 150 mm length with plastic handgrip intended for the injection of acrylic resin.
• 08031497000701 - BONE INJECTION NEEDLE diamond tip 11 Gauge 120 mm length: 2022-10-03 BONE INJECTION NEEDLE diamond tip 11 Gauge 120 mm length with plastic handgrip intended for the injection of acrylic resin.