Mazor X Accessories MAS1295

EUDAMEDFDA UDIFDA 510(k)

Class IIb (EU MDR)

Ref MAS1295

by Mazor Robotics Ltd.

Identity

Trade Name: MAZOR X Stealth Edition EUDAMED
Reference Marker FDA UDI
Generic Name: Stereotactic surgery system probe, reusable FDA UDI
Device Name: Mazor X Accessories EUDAMED
Model / Reference: MAS1295 EUDAMED
MAS1295-08S FDA UDI

Identifiers

Primary DI / UDI-DI: 07290115752748 EUDAMEDFDA UDI
Basic UDI-DI: 0763000B00026448E EUDAMED
510(k) Number: K230064 FDA UDI
FDA Product Code: OLO FDA UDI
LLZ FDA UDI
EMDN Code: Z12130401 STEREOTACTIC ORTHOPAEDIC SURGERY SYSTEMS EUDAMED
GMDN Term: Stereotactic surgery system probe, reusable FDA UDI

Classification

Device Class: Class IIb EUDAMED
Class II FDA UDI
Regulation Number: 882.4560 FDA UDI
892.2050 FDA UDI
Market of Registration: Netherlands EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

The Mazor X Accessories MAS1295 are reusable components designed for use with the Mazor X Stealth Edition spinal surgical system, a Class IIb medical device. These accessories support precision-guided spinal procedures, enhancing surgical accuracy and reducing operative time by integrating with robotic-assisted navigation systems.

Supplied as a reusable set, the accessories are intended for use in sterile operating environments and must undergo rigorous reprocessing between procedures. Compliance with FDA 510K and MDR regulations ensures their safety and performance, with no implantable or latex components. The device is non-active and does not administer medicine, adhering strictly to its designated surgical accessory role.

Frequently asked questions

Are the Mazor X Accessories MAS1295 designed for single-use or can they be reused across multiple procedures?

The Mazor X Accessories MAS1295 are explicitly marked as reusable components. They must undergo rigorous reprocessing between uses to ensure sterility and safety in sterile operating environments, as they are not intended for single-use.

What regulatory pathways have been followed for the Mazor X Accessories MAS1295, and who is the manufacturer?

The device has been authorized through the FDA 510K pathway and complies with MDR regulations. It is manufactured by Mazor Robotics Ltd., an Israeli company, and distributed by Medtronic B.V. as the authorized representative.

Do these accessories contain any implantable materials or latex, and are they compatible with robotic-assisted navigation systems?

The Mazor X Accessories MAS1295 do not contain implantable materials or latex. They are designed as non-active, reusable surgical accessories specifically for use with the Mazor X Stealth Edition spinal surgical system, which integrates with robotic-assisted navigation to enhance precision-guided spinal procedures.

How should the sterility of the Mazor X Accessories MAS1295 be maintained, and are there any special handling requirements?

The accessories are not sterile (marked as

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K200935	Class IIb	Active
FDA 510(k)	United States	FDA_510K	K180307	Class IIb	Active
FDA 510(k)	United States	FDA_510K	K172522	Class IIb	Active
FDA 510(k)	United States	FDA_510K	K163221	Class IIb	Active
FDA 510(k)	United States	FDA_510K	K203005	Class IIb	Active
EUDAMED	European Union	CE/MDR	0763000B00026448E	Class IIb	Active

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Manufacturer

Manufacturer: Mazor Robotics Ltd.
EUDAMED SRN: IL-MF-000020000
Authorised Representative: Medtronic B.V. NL-AR-000006050

Sources (3)

EUDAMED 9ee43155-3278-42d5-a253-cbb47bfba247 61 fields · synced Sep 18, 2026
FDA UDI e4404198-cfe4-41c3-9201-2d46a74df3dc 33 fields · synced May 30, 2026
FDA 510(k) K200935 1 fields · synced May 18, 2026