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NAVINETICS INC.

Last updated September 17, 2026

Information

Device	Model / Reference	Registries	Class	Status
NaviNetics Microdrive Adapter F	NN0170	FDA UDI	Class II	Active
NaviNetics MR Localizer Kit	NN0130	FDA UDI	Class II	Active
NaviNetics Skull Anchor Key and Drill	NN1215	FDA UDI	Class II	Active
NaviNetics Ground Truth Fixture	NN1300	FDA UDI	Class II	Active
NaviNetics Reusable Stereotactic System	NN1000	FDA UDI	Class II	Active
NaviNetics MR Localizer Tubing Kit	NN1240	FDA UDI	Class II	Active
NaviNetics Skull Anchor Extended Rescue Screw Kit	NN1600	FDA UDI	Class II	Active
NaviNetics Skull Anchor Key Kit	NN1210	FDA UDI	Class II	Active
NaviNetics Standard Skull Anchor Screw	NN1800	FDA UDI	Class II	Active
NaviNetics Key Placement Guide Kit	NN0110	FDA UDI	Class II	Active
NaviNetics Driver Handle	NN0110	FDA UDI	Class II	Active
NaviNetics Skull Anchor Rescue Screw Kit	NN1400	FDA UDI	Class II	Active
NaviNetics Skull Anchor Extended Screw Kit	NN1700	FDA UDI	Class II	Active
NaviNetics Cannula and Stylet Kit (To Target)	NN1250	FDA UDI	Class II	Active
NaviNetics CT Localizer Kit	NN0120	FDA UDI	Class II	Active
NaviNetics Cannula and Stylet Kit	NN1230	FDA UDI	Class II	Active
NaviNetics Reusable Stereotactic Frame	NN1100	FDA UDI	Class II	Active
NaviNetics Microdrive Adapter A	NN0160	FDA UDI	Class II	Active
NaviNetics D1 Stereotactic System	K210700	FDA 510(k)	Class II	Active
NaviNetics Reusable Stereotactic System (NN1000)	K231392	FDA 510(k)	Class II	Active

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

Date	Recall No.	Class	Status	Reason
Feb 26, 2024	Z-1478-2024	—	open, classified	Defective Skull Anchor Key. After attachment of the single use Skull Anchor Key to the patient, the user was unable to attach the CT Localizer to perform stereotactic Imaging. Attachment of the localizer is typically accomplished by fully screwing in the four thumbscrews of the localizer into the threaded holes found on the top surface of the Skull Anchor Key.