20100801

Organization name

ORTHOKEY ITALIA SRL

SRN

IT-MF-000026488

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

1 warning recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Italy; available across 4 countries total.

Trade name

not provided

UDI-DI code

08052675960013

Basic UDI-DI

B-08052675960013

Reference / catalog number

20100801

Issuing entity

GS1

Risk category

Class I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

PERSEUS is a medical device, that helps surgeon in the positioning of implant components during orthopaedic surgical procedure. It consists of four main components: an inertial sensor, to operate properly, is used together with a dedicated surgical instrument and an Apple iPad tablet, in which a dedicated software operates. The software is capable of processing the information sent by the sensor, guiding the doctor towards the correct positioning of the cutting guide.

Additional information URL

https://www.orthokey.com/

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z12011401SURGICAL NAVIGATION SYSTEM