Biotech Spinal Implant System

Primary DI

D-4049852SP1F4W5

Basic UDI-DI Code

B-4049852SP1F4W5

Reference

4049852SP1F4

Device Types

Single use Sterilization

Regulation

Eu Mdd

Classification

Eu Md Class 2b

Status

On The Market

Manufacturer

Biotech GmbH

Biotech Spinal Implant System is a non-active surgical implant system and includes fixative/osteosynthesis type of surgical devices used for the surgical treatment of various fractures and lesions affecting the vertebrae. The spinal fixator (DLC, DLP and CPS system) is made of a CoCr or titanium alloy (TIAI6V4). The plates used in the interventions have an axial compression effect in the fracture part - to clamp the fractured bone surfaces together - and also play a neutralizing or supporting / fixing role. Screws are used to secure implants, fix fractures, modify bone axes, or used as tension screws on bone plates. The implants must be able to withstand the stresses due to continuous tensile, compressive, torsional, bending and shear stresses. The Interbody Fusion (I/F) Cage are made of a PEEK or titanium alloy (TIAI6V4). The upper and lower contact surfaces are designed with retentive teeth and titanium spikes. The I/F Cages are hollow to accept packing of bone graft.

Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDD).