Cyber Surgery S.L.

Certificate C608701

Rev. 1Issued

Valid until: Sep 23, 2030

Certificate C608701 is a valid Quality management system issued to Cyber Surgery S.L. and registered in EUDAMED. Valid until September 23, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: C608701
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 2460C6087011

Validity

Issued: Sep 24, 2025
Valid from: Sep 24, 2025
Valid until: Sep 23, 2030

Manufacturer

Manufacturer: Cyber Surgery S.L.
Manufacturer SRN: ES-MF-000042958
Manufacturer country: Spain

Notified body

Notified body
Notified body SRN: 2460
Notified body country: Norway

Covered devices

No specific devices are listed for this certificate.

Characteristics

: Yes
: No
: No
: No
: Yes
: No
: No
: Yes
: Yes
: No
: No

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa10Class I10Class IIb2

22 scopes

Cyber Surgery Spine Robotic Assistant – Cyber Surgery Spine Robotic Assistant is a robotic assistant designed to be used on transpedicular screw planification for spinal fusion. The system guides the surgeon and facilitates the surgical procedure.
Class IIb
The Cyber Surgery Invasive Surgical Instruments are reusable surgical instruments intended for use with Cyber Surgery Spine Robotic Assistant during the spinal surgery to perform invasive steps of the clinical procedures.
Class IIa
The Cyber Surgery Invasive Surgical Instruments are reusable surgical instruments intended for use with Cyber Surgery Spine Robotic Assistant during the spinal surgery to perform invasive steps of the clinical procedures.
Class IIa
The Cyber Surgery Invasive Surgical Instruments are reusable surgical instruments intended for use with Cyber Surgery Spine Robotic Assistant during the spinal surgery to perform invasive steps of the clinical procedures.
Class IIa
The Cyber Surgery Invasive Surgical Instruments are reusable surgical instruments intended for use with Cyber Surgery Spine Robotic Assistant during the spinal surgery to perform invasive steps of the clinical procedures.
Class IIa
The Cyber Surgery Invasive Surgical Instruments are reusable surgical instruments intended for use with Cyber Surgery Spine Robotic Assistant during the spinal surgery to perform invasive steps of the clinical procedures.
Class IIa
The Cyber Surgery Spine Fiducial - is a single-use, sterile (gamma radiation). The Cyber Surgery Spine Fiducial is intended for use with Cyber Surgery Spine Robotic Assistant as an aid during image registration process to perform the recording of the patient’s position by intraoperative imaging.
Class I
The Cyber Surgery Non-Invasive Surgical Instruments are reusable surgical instruments intended for use with Cyber Surgery Spine Robotic Assistant during the spinal surgery to perform non-invasive steps of the clinical procedures.
Class I
The Cyber Surgery Non-Invasive Surgical Instruments are reusable surgical instruments intended for use with Cyber Surgery Spine Robotic Assistant during the spinal surgery to perform non-invasive steps of the clinical procedures.
Class I
The Cyber Surgery Non-Invasive Surgical Instruments are reusable surgical instruments intended for use with Cyber Surgery Spine Robotic Assistant during the spinal surgery to perform non-invasive steps of the clinical procedures.
Class I
The Cyber Surgery Non-Invasive Surgical Instruments are reusable surgical instruments intended for use with Cyber Surgery Spine Robotic Assistant during the spinal surgery to perform non-invasive steps of the clinical procedures.
Class I
ALAYA Spine Robotic Assistant
Class IIb
ALAYA Spine Bone Clamps
Class IIa
ALAYA Spine Dilator
Class IIa
ALAYA Spine Awl
Class IIa
ALAYA Spine Drill Guide
Class IIa
ALAYA Spine K-Wire adapter
Class IIa
ALAYA Spine Fiducial
Class I
ALAYA Spine AB Tool Guide
Class I
ALAYA Spine C Tool Guide
Class I

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