Confidence Spinal Cement System

Device Name

CONFIDENCE Spinal Cement System - 7cc Kit

Model / Reference

CONFIDENCE Spinal Cement System - 7cc Kit, 283907000

Primary DI / UDI-DI

10705034209616

Basic UDI-DI

0705034a0009569

EMDN Code

P099002 Orthopaedic cement preparation and application devices and kits

Device Class

Class III

Medical Purpose

The CONFIDENCE SPINAL CEMENT SYSTEM is intended for percutaneous delivery of CONFIDENCE High Viscosity Spinal Cement, which is indicated for the augmentation of pathological fractures of the vertebral body in skeletally mature patients using vertebroplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma). CONFIDENCE High Viscosity Spinal cement is for single-use and is not reusable.

EUDAMED SRN

CH-PR-000034475

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