Navinetics Inc

Rochester, MN, US

NAVINETICS INC. appears in FDA device records in Rochester, MN. FDA records list 2 510(k) clearances between 2021-06-17 and 2023-07-14, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 2
PMA records: 0
Recall records: 1
Registered establishments: 1

510(k) clearance history

FDA records hold 2 510(k) clearances for Navinetics Inc between 2021 and 2023. The busiest year on record is 2021, with 1. The most recent is 2023, with 1.

Clearances by year, as a table

510(k) clearance decisions for Navinetics Inc, by decision year
Year	Clearances
2021	1
2023	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K231392	NaviNetics Reusable Stereotactic System (NN1000)	HAW	Substantially Equivalent	2023-07-14
K210700	NaviNetics D1 Stereotactic System	HAW	Substantially Equivalent	2021-06-17

Registered establishments

FDA registered establishments for Navinetics Inc, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3023194190	3023194190	NAVINETICS INC.	206 South Broadway, Rochester, MN 55904 US	2026	HAW

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

HAWNeurological Stereotaxic Instrument

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1478-2024	NaviNetics Skull Anchor Key and Drill Kit, REF NN1215	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.	Class II	2024-02-26	Open, Classified

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain