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Clearpoint Neuro, Inc.

United States·US-MF-000010239

Last updated September 17, 2026

Information

Country: United States
Address: 6349, Paseo Del Lago , Carlsbad, United States
Website: www.clearpointneuro.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 949-900-6833
PRRC Contact: Megan Faulkenberry
EUDAMED SRN: US-MF-000010239
FDA FEI Number: 3028006458
DUNS Number: 119078557

Catalogue (204)

Page 4 of 5

Device	Model / Reference	Registries	Class	Status
ClearPoint	CP-SFW-11-203	FDA UDI	Class II	Active
ClearPoint	CP-FFS-01	FDA UDI	Class II	Active
ClearPoint Mobile Equipment Cart	CP-MEC-01	FDA UDI	Class I	Active
ClearPoint Siemens Aera / Skyra Multi-Positional HFF	CP-MPHFF-122-01	EUDAMEDFDA UDI	Class I	Active
SmartFrame Guide Tubes (Set)	NGS-GT-01	EUDAMEDFDA UDI	Class I	Active
MR Bore Drape w/Extension (IMRIS)	NGS-PD-04-E	EUDAMED	Class I	Active
ClearPoint Inflexion Aera-Skyra HFF	CP-INHFF-122-01	EUDAMEDFDA UDI	Class I	Active
SmartFrame XG Exchangeable Device Guides – Europe	NGS-XG-01-E	EUDAMED	Class I	Active
MR Patient Drape (IMRIS)	NGS-PD-05-E	EUDAMED	Class I	Active
Inflexion IMRIS Universal HFF	CP-INHFF-232-01	EUDAMEDFDA UDI	Class I	Active
ClearPoint IMRIS Aera / Skyra Multi-Positional HFF	CP-MPHFF-242-01	EUDAMEDFDA UDI	Class I	Active
SmartFrame XG Targeting Cannula	NGS-TC-01	EUDAMEDFDA UDI	Class I	Active
Inflexion Siemens Sola-Vida HFF	CP-INHFF-132-01	EUDAMEDFDA UDI	Class I	Active
ClearPoint Maestro Brain Model	K213645	FDA 510(k)	Class II	Active
ClearPoint Array System (version 1.1)	K214040	FDA 510(k)	Class II	Active
SmartFrame OR	K233141	FDA 510(k)	Class II	Active
ClearPoint Array System (Version 1.2)	K232102	FDA 510(k)	Class II	Active
ClearPointer Optical Navigation Wand	K233155	FDA 510(k)	Class II	Active
ClearPoint Array System	K202575	FDA 510(k)	Class II	Active
ClearPoint System (Software Version 3.0)	K243657	FDA 510(k)	Class II	Active
ClearPoint System	K222519	FDA 510(k)	Class II	Active
Bone Anchor (NGS-BA-01)	K233703	FDA 510(k)	Class II	Active
ClearPoint System (Software Version 2.2)	K233243	FDA 510(k)	Class II	Active
ClearPoint Bone Screw Fiducials	K233144	FDA 510(k)	Class II	Active
SmartFlow Neuro Cannula	DEN240023	FDA 510(k)	Class II	Active
SmartFrame XG – Europe	NGS-SF-02-11-E	EUDAMED	Class IIa	Active
ClearPoint Siemens Sola / Vida Multi-Positional HFF	CP-MPHFF-132-01	EUDAMEDFDA UDI	Class I	Active
ClearPoint Philips Achieva Table Multi-Positional HFF	CP-MPHFF-412-01	EUDAMEDFDA UDI	Class I	Active
SmartTwist MR Hand Drill	NGS-HD-01	EUDAMEDFDA UDI	Class I	Active
ClearPoint IMRIS Universal Multi-Positional HFF	CP-MPHFF-232-01	EUDAMEDFDA UDI	Class I	Active
ClearPoint GE HDx Table Multi-Positional HFF	CP-MPHFF-312-01	EUDAMEDFDA UDI	Class I	Active
ClearPoint SMS Avanto Table Multi-Positional HFF	CP-MPHFF-112-01	EUDAMEDFDA UDI	Class I	Active
SmartFrame Scalp Mount Base – Europe	NGS-SM-01-E	EUDAMED	Class IIa	Active
Inflexion IMRIS Aera-Skyra HFF	CP-INHFF-242-01	EUDAMEDFDA UDI	Class I	Active
SmartFrame XG Exchangeable Device Guide, 4.5 mm – Europe	NGS-XG-02-E	EUDAMED	Class I	Active
Inflexion Avanto HFF	CP-INHFF-112-01	EUDAMEDFDA UDI	Class I	Active
Inflexion Philips Ingenia HFF	CP-INHFF-422-01	EUDAMEDFDA UDI	Class I	Active
ClearPoint Multi-Positional Upper Fixation Frame Screws	CP-FFSMPU-01	EUDAMEDFDA UDI	Class I	Active
Inflexion GE 750w HFF	CP-INHFF-332-01	EUDAMEDFDA UDI	Class I	Active
ClearPoint Multi-Positional Lower HFF Screws for GE, Siemens and IMRIS	CP-FFSMPL-01	EUDAMEDFDA UDI	Class I	Active
MR Neuro Drape Tapered w/Extension (GE)-Long	NGS-PD-03-L-E	EUDAMED	Class I	Active
SmartGrid Planning Grid	NGS-SG-01-11	EUDAMEDFDA UDI	Class IIa	Active
ClearPoint GE HDw (450w) Table Multi-Positional HFF	CP-MPHFF-322-01	EUDAMEDFDA UDI	Class I	Active
MR Neuro Drape Tapered (Siemens/Philips)-Long	NGS-PD-02-L-E	EUDAMED	Class I	Active
Depth Stop, 6 Pack	NGS-DS-06	EUDAMEDFDA UDI	Class I	Active
ClearPoint IMRIS with Base Multi-Positional HFF	CP-MPHFF-211-01	EUDAMEDFDA UDI	Class I	Active
ClearPoint Philips Igenia Table Multi-Positional HFF	CP-MPHFF-422-01	EUDAMEDFDA UDI	Class I	Active
SmartFrame Thumb Wheel Extension Set	NGS-TE-01	EUDAMEDFDA UDI	Class I	Active
Inflexion GE Premier	CP-INHFF-342-01	EUDAMEDFDA UDI	Class I	Active
ClearPoint GE 750w Table Multi-Positional HFF	CP-MPHFF-332-01	EUDAMEDFDA UDI	Class I	Active

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