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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 the device name listed in this FDA 510(k) record. The listed applicant is SI-BONE, Inc.. It received FDA 510(k) clearance on 2024-02-23 under 510(k) 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. The listed applicant is SI-BONE, Inc.. The 510(k) number is K232800.

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

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

Who is the listed applicant for Navigation Tracking 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 Navigation Tracking Instruments?

The FDA product code for Navigation Tracking Instruments is OLO.

Related Clinical Trials

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NCT05870488iFuse TORQ for the Treatment of Sacroiliac Joint DysfunctionACTIVE_NOT_RECRUITINGNCT07530497Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring FracturesRECRUITINGNCT07565545Posterior-Inferior Intra-articular Cortical Piercing Titanium Implant for Sacroiliac Joint Fusion: Evaluation of Safety and Effectiveness OutcomesNOT_YET_RECRUITING

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 SystemK251780iGPS Navigation InstrumentsK241504iFuse TORQ TNT™ Implant SystemK241574iFuse TORQ® Implant SystemK233508iFuse 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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