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MAZOR ROBOTICS LTD

Israel·IL-MF-000020000

Last updated May 24, 2026

What MAZOR ROBOTICS LTD makes

The company manufactures reusable and single-use surgical instruments and systems for stereotactic and orthopaedic procedures, including robotic frame connection kits, cranial drill bits, and specialized clamps like the muscle biopsy clamp. Their portfolio also includes general and orthopaedic surgical procedure kits, patient drapes, and reusable instrument trays designed for precision-guided surgeries. Multi-purpose stereotactic systems and spinal instrumentation, such as guiding adaptors and Schanz screws, are also part of their offerings.

All listed devices fall under Class II regulatory classification and are registered in the FDA’s Unique Device Identifier (UDI) database. The company is based in Israel and adheres to relevant international standards for surgical and orthopaedic instrumentation.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Mazor Robotics Ltd manufacture?

Mazor Robotics Ltd specializes in surgical instruments and systems primarily for stereotactic and orthopaedic procedures. Their product range includes reusable items like stereotactic surgery probes, instrument trays, and robotic frame connection kits, as well as single-use items such as orthopaedic and general surgical procedure kits, patient drapes, and specialized tools like muscle biopsy clamps. They also produce multi-purpose stereotactic surgery systems and spinal instrumentation, including guiding adaptors and screws.

Where is Mazor Robotics Ltd based?

Mazor Robotics Ltd is based in Israel. The company’s headquarters and manufacturing operations are located within the country, though specific regional offices or production sites may vary. This location aligns with the company’s focus on developing advanced surgical technologies for global markets.

Which regulatory registries list Mazor Robotics Ltd’s devices?

Mazor Robotics Ltd’s devices are registered in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance tracking for medical devices in the United States. The inclusion in this database reflects the company’s adherence to FDA requirements for device identification and reporting.

How are Mazor Robotics Ltd’s devices classified under medical device regulations?

All of Mazor Robotics Ltd’s listed devices fall under Class II regulatory classification. This classification applies to devices that generally pose moderate risk and require special controls to ensure their safety and effectiveness, such as surgical instruments, orthopaedic implants, and precision-guided systems. Class II devices undergo rigorous evaluation to balance risk mitigation with accessibility for clinical use.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: Israel
Address: 1, HaEshel Street (Building C), Caesarea Business Park, Caesarea , Israel
Website: medtronic.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +97246187100
PRRC Contact: Marina Hefetz Lerner
EUDAMED SRN: IL-MF-000020000
FDA FEI Number: —
DUNS Number: 532681590

Catalogue (533)

Page 10 of 11

Device	Model / Reference	Registries	Class	Status
SA Cross Bar	MAS0766-02S	FDA UDI	Class II	Active
Head Pin 2.5x60mm	MAS2267-03	FDA UDI	Class II	Unknown
Snapshot Tracker Kit	KIT0898-05	FDA UDI	Class II	Active
Arm 2-3	MAS1733-02	FDA UDI	Class II	Active
MIST Bridge	MAS2568-03	FDA UDI	Class II	Unknown
Surgical Instrument Expansion Set	KIT0676-01	FDA UDI	Class II	Active
SA 3.0mm Long Drill	MAS0366-05S	FDA UDI	Class II	Active
Peteron	MAS0767-03	FDA UDI	Class II	Active
Short Drill 3x80mm	MAS2264-04	FDA UDI	Class II	Unknown
Renaissance Short Drill Adaptor	KIT0757-01	FDA UDI	Class II	Unknown
SA MIS Bridge	MAS0608-04S	FDA UDI	Class II	Active
Long drill 3x80mm, 10 pack	KIT0738-02	FDA UDI	Class II	Unknown
Mazor X System- Refurbished	TPL0059-06R	FDA UDI	Class II	Active
4mm x 150mm Schanz Screw, Qty: 10	KIT0565-03	FDA UDI	Class II	Active
Scan & Plan Clamp Disposable Kit	KIT0590-04	FDA UDI	Class II	Active
MIST Bridge	MAS2438-01	FDA UDI	Class II	Unknown
Renaissance Multi Directional Bridge Set	KIT0617-02	FDA UDI	Class II	Active
Short Drill 3.0x30mm	MAS2261-04	FDA UDI	Class II	Unknown
Reference Marker	MAS1295-07S	FDA UDI	Class II	Active
Short Cannula	MAS2249-06S	FDA UDI	Class II	Active
Mazor X Instrument Set Case 2	MAS2307-03S	FDA UDI	Class II	Active
Mazor X Pelvic Attachment Set	KIT1314-01	FDA UDI	Class II	Active
Dual Clamp	MAS1355-05	FDA UDI	Class II	Unknown
MIST Bridge	MAS2568-04S	FDA UDI	Class II	Active
Head Pin 2.5x60mm, 10 pack	KIT0731-01	FDA UDI	Class II	Unknown
Schanz Screw 4x120mm, 10 pack w/o CE	KIT0001798-01	FDA UDI	Class II	Active
Schanz screw 4mmx80, 10 pack	KIT0729-05	FDA UDI	Class II	Active
Surgical System Sleeve, 10 Pack	KIT0953-02	FDA UDI	Class II	Active
Blunt	MAS2255-05	FDA UDI	Class II	Unknown
Renaissance X System	K152041	FDA 510(k)	Class II	Active
Mazor X System / Mazor X Stealth Edition	K251316	FDA 510(k)	Class II	Active
Mazor X System (Mazor X Stealth Edition)	K182077	FDA 510(k)	Class II	Active
Renaissance X System	K140167	FDA 510(k)	Class II	Active
Renaissance	K120812	FDA 510(k)	Class II	Active
Mazor X System (Mazor X Stealth Edition)	K230064	FDA 510(k)	Class II	Active
Renaissance System	K110911	FDA 510(k)	Class II	Active
Renaissance System	K113228	FDA 510(k)	Class II	Active
MAZOR X Stealth Edition	KIT1490	EUDAMEDFDA UDI	Class I	Active
MAZOR X Stealth Edition	KIT0739	EUDAMEDFDA UDI	Class IIb	Active
MAZOR X Stealth Edition	KIT0854	EUDAMEDFDA UDI	Class IIb	Active
MAZOR X Stealth Edition	KIT0732	EUDAMEDFDA UDI	Class IIb	Active
MAZOR X Stealth Edition	MAS2265	EUDAMEDFDA UDI	Class IIb	Active
MAZOR X Stealth Edition	MAS2260	EUDAMEDFDA UDI	Class IIb	Active
MAZOR X Stealth Edition	MAS2255	EUDAMEDFDA UDI	Class IIb	Active
MAZOR X Stealth Edition	MAS2264	EUDAMEDFDA UDI	Class IIb	Active
MAZOR X Stealth Edition	KIT0762	EUDAMEDFDA UDI	Class IIb	Active
MAZOR X Stealth Edition	KIT2608	EUDAMEDFDA UDI	Class IIb	Active
MAZOR X Stealth Edition	KIT2438	EUDAMEDFDA UDI	Class IIb	Active
MAZOR X Stealth Edition	KIT0898	EUDAMEDFDA UDI	Class I	Active
MAZOR X Stealth Edition	MAS2241	EUDAMEDFDA UDI	Class IIb	Active

Related Companies

Authorised Representatives

Medtronic B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Mazor Robotics Ltd has one FDA recall record initiated on November 26, 2014, which is marked as terminated. The recall was due to a potential issue where the carousel position pin (locker) could cause the carousel upper plate to pop out, allowing the carousel to move inadvertently.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Nov 26, 2014	Z-0609-2019	—	terminated	In some situations the carousel position pin (locker) may cause the carousel upper plate to pop out and the carousel may then inadvertently move.