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FDA 510(k)

Navigation Tracking Instruments

K-Number: K232800 · 2024-02-23

ApplicantSI-BONE, Inc.
Decision Date2024-02-23
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Navigation Tracking Instruments is a medical device manufactured by SI-BONE, Inc.. It received FDA 510(k) clearance on 2024-02-23 under approval number K232800. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Navigation Tracking Instruments?

Navigation Tracking Instruments is a medical device that received FDA 510(k) clearance on 2024-02-23. It is manufactured by SI-BONE, Inc.. The 510(k) number is K232800.

When was Navigation Tracking Instruments approved by the FDA?

Navigation Tracking Instruments received FDA 510(k) clearance on 2024-02-23, under approval number K232800.

What company makes Navigation Tracking Instruments?

Navigation Tracking Instruments is manufactured by SI-BONE, Inc..

What is the FDA product code for Navigation Tracking Instruments?

The FDA product code for Navigation Tracking Instruments is OLO.

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Official Source

View on FDA Database →

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

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