iGPS Navigation Instruments
K-Number: K251780 · 2025-09-15
ApplicantSI-BONE, Inc.
Decision Date2025-09-15
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
iGPS Navigation Instruments is a medical device manufactured by SI-BONE, Inc.. It received FDA 510(k) clearance on 2025-09-15 under approval number K251780. 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 iGPS Navigation Instruments?
iGPS Navigation Instruments is a medical device that received FDA 510(k) clearance on 2025-09-15. It is manufactured by SI-BONE, Inc.. The 510(k) number is K251780.
When was iGPS Navigation Instruments approved by the FDA?
iGPS Navigation Instruments received FDA 510(k) clearance on 2025-09-15, under approval number K251780.
What company makes iGPS Navigation Instruments?
iGPS Navigation Instruments is manufactured by SI-BONE, Inc..
What is the FDA product code for iGPS Navigation Instruments?
The FDA product code for iGPS Navigation Instruments is OLO.
Related Clinical Trials
Other Devices by SI-BONE, Inc.
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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.