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FDA 510(k)

NaviNetics D1 Stereotactic System

K-Number: K210700 · 2021-06-17

Decision Date2021-06-17
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NaviNetics D1 Stereotactic System is a medical device manufactured by Navinetics, Inc.. It received FDA 510(k) clearance on 2021-06-17 under approval 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. It is manufactured by Navinetics, Inc.. The 510(k) number is K210700.

When was NaviNetics D1 Stereotactic System approved by the FDA?

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

What company makes NaviNetics D1 Stereotactic System?

NaviNetics D1 Stereotactic System is manufactured by Navinetics, Inc..

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

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

Related Clinical Trials

Other Devices by Navinetics, Inc.

Related Devices (Code: HAW)

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.