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FDA 510(k)

NaviNetics D1 Stereotactic System

K-Number: K210700 · 2021-06-17

ApplicantNavinetics, Inc.
Decision Date2021-06-17
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NaviNetics D1 Stereotactic System is the device name listed in this FDA 510(k) record. The listed applicant is Navinetics, Inc.. It received FDA 510(k) clearance on 2021-06-17 under 510(k) number K210700. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NaviNetics D1 Stereotactic System?

NaviNetics D1 Stereotactic System is a medical device that received FDA 510(k) clearance on 2021-06-17. The listed applicant is Navinetics, Inc.. The 510(k) number is K210700.

When did NaviNetics D1 Stereotactic System receive FDA 510(k) clearance?

NaviNetics D1 Stereotactic System received FDA 510(k) clearance on 2021-06-17, under 510(k) number K210700.

Who is the listed applicant for NaviNetics D1 Stereotactic System?

The FDA 510(k) record lists Navinetics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NaviNetics D1 Stereotactic System?

The FDA product code for NaviNetics D1 Stereotactic System is HAW.

Other records listing Navinetics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231392NaviNetics Reusable Stereotactic System (NN1000)

Related Devices (Code: HAW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261932Leksell® Vantage Stereotactic SystemElekta Solutions ABK253663Zeta Navigation SystemZeta Surgical, Inc.K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical PartnersK250893Ball Joint Guide Array (66295)Bayer Medical Care, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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