Question 1

What types of medical devices does Renishaw Mayfield SARL manufacture?

Accepted Answer

Renishaw Mayfield SARL specializes in neuromate systems, which are frame-based and frameless stereotactic devices used in neurosurgery. These include the Neuromate Frameless Gen II and Neuromate Gen III models, designed to guide surgical instruments with high precision during brain procedures. The devices are tailored for stereotactic applications, ensuring accurate targeting in neurosurgical interventions.

Question 2

Where is Renishaw Mayfield SARL based, and what does that mean for regulatory compliance?

Accepted Answer

Renishaw Mayfield SARL is headquartered in France, which means its devices must comply with both EU and international regulatory standards. Since the company’s neuromate systems are classified as Class II devices, they undergo rigorous evaluation to ensure safety and performance. The French location also influences how these devices are registered and listed in global markets, such as the FDA’s 510(k) pathway in the U.S.

Question 3

Which regulatory registries list Renishaw Mayfield SARL’s neuromate devices?

Accepted Answer

Renishaw Mayfield SARL’s neuromate devices are listed under the FDA’s 510(k) clearance process in the United States. This pathway demonstrates that the devices meet FDA requirements for safety and effectiveness as medical devices. While the specific registry listings may vary by country, the FDA clearance is a key authorization for these products in the U.S. market.

Question 4

How are Renishaw Mayfield SARL’s neuromate devices classified, and why does that matter?

Accepted Answer

Renishaw Mayfield SARL’s neuromate systems are classified as Class II medical devices. This classification indicates that they pose a moderate risk and require special controls beyond general good manufacturing practices to ensure their safety and performance. Class II designation means these devices undergo additional scrutiny during regulatory review, including clinical evaluations and validation testing, to confirm their effectiveness in stereotactic neurosurgical applications.

Device	Model / Reference	Registries	Class	Status
neuro\|mate® - Bone fixation pin screwdriver	Fiducial fixation kit	FDA UDI	Class II	Unknown
neuro\|mate® - Frameless Head-holder support	Head-holder support	FDA UDI	Class II	Unknown
neuro\|mate® - Long stop collar for drill	Fiducial fixation kit	FDA UDI	Class II	Unknown
neuromate tool guide	Tool guide OD15 - Microdrive FHC stardrive - Leksell	FDA UDI	Class II	Active
NMControl	v.1.6.	FDA UDI	Class II	Active
neuro\|mate® - Fiducial fixation Kit	Fiducial fixation kit	FDA UDI	Class II	Unknown
neuro\|mate® - Frameless Head-holder ring	Frameless Head-holder kit	FDA UDI	Class II	Unknown
neuromate planning station hardware	PC Cart (Workstation Cart)	FDA UDI	Class II	Active
neuro\|mate® - Tool-holder locking screw	Screw	FDA UDI	Class II	Active
neuromate tool guide	Tool guide OD15 - Standard guide (XX = internal diameter)	FDA UDI	Class II	Active
neuro\|mate® - Frameless Head-holder - Clip	Frameles head-holder kit	FDA UDI	Class II	Unknown
neuromate planning station hardware	neuroinspire PC - Desktop US	FDA UDI	Class II	Active
neuro\|mate® - Registration frame	Tool-holder	FDA UDI	Class II	Active
neuro\|mate® - Temporary implant insert	Fiducial fixation kit	FDA UDI	Class II	Unknown
neuro\|mate® frameless Gen II stereotactic system	neuro\|mate v1.5	FDA UDI	Class II	Active
neuro\|mate® - Frameless Head-holder kit	Frameless Head-holder kit	FDA UDI	Class II	Unknown
neuro\|mate® - Adaptation for Leksell Model G Elekta frame	Adaptation for frame	FDA UDI	Class II	Active
neuro\|mate® - Adaptation for CRW Integra frame	Adaptation for frame	FDA UDI	Class II	Active
neuro\|mate® - Screwdriver for the temporary implant insert	Fiducial fixation kit	FDA UDI	Class II	Unknown
neuro\|mate® - Laser tool-holder	Tool-holder	FDA UDI	Class II	Active
neuromate tool guide	Tool guide OD15 - Long guide (XX = internal diameter)	FDA UDI	Class II	Active
neuro\|mate® - Bone fixation pin Diameter 3, 5mm	Fiducial fixation kit	FDA UDI	Class II	Unknown
neuro\|mate® - Bone fixation drill 3mm	Fiducial fixation kit	FDA UDI	Class II	Unknown
neuro\|mate® - CT Scanner Localizer	Localizer	FDA UDI	Class II	Unknown
neuromate tool guide	Tool guide OD15 - Microdrive FHC microtargeting	FDA UDI	Class II	Active
neuro\|mate® - Registration tool-holder	Tool-holder	FDA UDI	Class II	Unknown
neuromate tool guide	Tool guide OD15 - Monteris laser Ablation Kit	FDA UDI	Class II	Active
neuro\|mate® - Tool-holder fixation screw	Screw	FDA UDI	Class II	Active
neuromate tool-holder	neuro\|mate Standard tool-holder	FDA UDI	Class II	Active
neuro\|mate® Gen III stereotactic system	neuro\|mate v1.5	FDA UDI	Class II	Active
neuromate neuroinspire software	neuroinspire planning software	EUDAMEDFDA UDI	Class II	Active
neuromate - neuroinspire software	neuroinspire SW Atlas Module	FDA UDI	Class II	Active
Neuromate Planning Station Hardware	neuroinspire PC - Laptop US	FDA UDI	Class II	Active
neuromate tool guide	Tool guide OD15 - Standard guide with tool locking system	FDA UDI	Class II	Active
neuro\|mate® - MRI Localizer	Localizer	FDA UDI	Class II	Unknown
neuro\|mate® - Adaptation for Fischer ZD frame	Adaptation for frame	FDA UDI	Class II	Unknown
Neuromate Frameless Gen Ii	K132755	FDA 510(k)	Class II	Active
neuromate Gen III	K181706	FDA 510(k)	Class II	Active
neuromate Gen III	K180206	FDA 510(k)	Class II	Active

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