RX78

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

08052675961034

Basic UDI-DI

805267596RoboticUnit77

Reference / catalog number

RX78

Issuing entity

GS1

Risk category

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Robotic system to assist the surgeon intraoperatively during total knee arthoplasty (TKA). The robotic unit must be used in combination with the navigation unit.

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.

• Z12020101ROBOT-ASSISTED ENDOSCOPIC SURGERY SYSTEMS