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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is SI-BONE, Inc.. It received FDA 510(k) clearance on 2025-09-15 under 510(k) 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. The listed applicant is SI-BONE, Inc.. The 510(k) number is K251780.

When did iGPS Navigation Instruments receive FDA 510(k) clearance?

iGPS Navigation Instruments received FDA 510(k) clearance on 2025-09-15, under 510(k) number K251780.

Who is the listed applicant for iGPS Navigation Instruments?

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

What is the FDA product code for iGPS Navigation Instruments?

The FDA product code for iGPS Navigation Instruments is OLO.

Related Clinical Trials

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Other records listing SI-BONE, 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.

K253488iFuse INTRA Ti™ Implant SystemK253094iFuse Bedrock Granite Implant SystemK241504iFuse TORQ TNT™ Implant SystemK241574iFuse TORQ® Implant SystemK232800Navigation Tracking InstrumentsK233508iFuse Bedrock Granite® Implant System

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Related Devices (Code: OLO)

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.

K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation CentreK261205SPINEART Navigation Instrument SystemSpineart SAK262121Ion-L Navigated InstrumentsSurGenTec, LLCK261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K261113Op.n™ Spine Navigation and Robotic GuidanceEcential RoboticsK261852OTS HipOrtoma AB

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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