Biotech Spinal Implant System

Organization name

Biotech GmbH

SRN

DE-MF-000023586

Manufacturer status

Active

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• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Croatia; available across 3 countries total.

Trade name

Biotech Spinal Implant System

UDI-DI code

D-4049852SP1F4W5

Basic UDI-DI

B-4049852SP1F4W5

Reference / catalog number

4049852SP1F4

Issuing entity

EUDAMED

Risk category

Class IIb

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

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.

Additional information URL

https://biotech-medical.com/bio/

Clinical sizes

• In this device group a huge number of devices are included with different sizes. All devices with all their exact names, sizes, reference numbers will attached to the documents in an excel file — 0 MU50

• P090799SPINAL PROSTHESES AND STABILISATION SYSTEMS - OTHER
• P09070399IMPLANTABLE SPINAL STABILISATION OR FIXATION SYSTEMS - OTHER
• P09070305SPINAL STABILISERS, DYNAMIC TYPE
• P09070304SPINE FIXATION SYSTEM CONNECTORS
• P09070302THORACOLUMBOSACRAL FIXATION SYSTEMS
• P09070301CERVICAL FIXATION SYSTEMS
• P09070201DISC PROSTHESES
• P09070199SPINAL FUSION SYSTEMS - OTHER
• P09070101SPINAL CAGES

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