Question 1

What types of medical devices does Mazor Robotics Ltd manufacture?

Accepted Answer

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.

Question 2

Where is Mazor Robotics Ltd based?

Accepted Answer

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.

Question 3

Which regulatory registries list Mazor Robotics Ltd’s devices?

Accepted Answer

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.

Question 4

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

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
MAZOR X Stealth Edition	KIT1488	EUDAMEDFDA UDI	Class I	Active
MAZOR X Stealth Edition	MAS2249	EUDAMEDFDA UDI	Class IIb	Active
MAZOR X Stealth Edition	KIT0896	EUDAMEDFDA UDI	Class I	Active
MAZOR X Stealth Edition	MAS2242	EUDAMEDFDA UDI	Class IIb	Active
MAZOR X Stealth Edition	KIT0736	EUDAMEDFDA UDI	Class IIb	Active
MAZOR X Stealth Edition	MAS2330	EUDAMEDFDA UDI	Class IIb	Active
MAZOR X Stealth Edition	KIT0737	EUDAMEDFDA UDI	Class IIb	Active
MAZOR X Stealth Edition	KIT2637	EUDAMEDFDA UDI	Class IIb	Active
MAZOR X Stealth Edition	KIT0733	EUDAMEDFDA UDI	Class IIb	Active
MAZOR X Stealth Edition	KIT2865	EUDAMEDFDA UDI	Class IIb	Active
MAZOR X Stealth Edition	KIT0893	EUDAMEDFDA UDI	Class I	Active
MAZOR X Stealth Edition	KIT0897	EUDAMEDFDA UDI	Class I	Active
MAZOR X Stealth Edition	KIT2856	EUDAMEDFDA UDI	Class IIb	Active
MAZOR X Stealth Edition	KIT0894	EUDAMEDFDA UDI	Class I	Active
MAZOR X Stealth Edition	KIT2643	EUDAMEDFDA UDI	Class IIb	Active
MAZOR X Stealth Edition	KIT2851	EUDAMEDFDA UDI	Class IIb	Active
MAZOR X Stealth Edition	KIT2859	EUDAMEDFDA UDI	Class IIb	Active
MAZOR X Stealth Edition	KIT0738	EUDAMEDFDA UDI	Class IIb	Active
MAZOR X Stealth Edition	KIT3010	EUDAMEDFDA UDI	Class IIb	Active
MAZOR X Stealth Edition	MAS2245	EUDAMEDFDA UDI	Class IIb	Active
MAZOR X Stealth Edition	KIT2866	EUDAMEDFDA UDI	Class IIb	Active
MAZOR X Stealth Edition	KIT2867	EUDAMEDFDA UDI	Class IIb	Active
MAZOR X Stealth Edition	KIT2313	EUDAMEDFDA UDI	Class IIb	Active
MAZOR X Stealth Edition	MAS2259	EUDAMEDFDA UDI	Class IIb	Active
MAZOR X Stealth Edition	KIT0895	EUDAMEDFDA UDI	Class I	Active
MAZOR X Stealth Edition	KIT2382	EUDAMEDFDA UDI	Class IIb	Active
MAZOR X Stealth Edition	KIT2868	EUDAMEDFDA UDI	Class IIb	Active
MAZOR X Stealth Edition	KIT0734	EUDAMEDFDA UDI	Class IIb	Active
MAZOR X Stealth Edition	KIT2383	EUDAMEDFDA UDI	Class IIb	Active
MAZOR X Stealth Edition	KIT2712	EUDAMEDFDA UDI	Class IIb	Active
MAZOR X Stealth Edition	KIT0899	EUDAMEDFDA UDI	Class I	Active
MAZOR X Stealth Edition	MAS2240	EUDAMEDFDA UDI	Class IIb	Active
MAZOR X Stealth Edition	MAS1295	EUDAMEDFDA UDI	Class IIb	Active

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