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FDA 510(k)

iFuse Implant System- iFuse Navigation

K-Number: K172268 · 2017-10-31

ApplicantSI-BONE, Inc.
Decision Date2017-10-31
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

iFuse Implant System- iFuse Navigation 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 2017-10-31 under 510(k) number K172268. 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 iFuse Implant System- iFuse Navigation?

iFuse Implant System- iFuse Navigation is a medical device that received FDA 510(k) clearance on 2017-10-31. The listed applicant is SI-BONE, Inc.. The 510(k) number is K172268.

When did iFuse Implant System- iFuse Navigation receive FDA 510(k) clearance?

iFuse Implant System- iFuse Navigation received FDA 510(k) clearance on 2017-10-31, under 510(k) number K172268.

Who is the listed applicant for iFuse Implant System- iFuse Navigation?

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 iFuse Implant System- iFuse Navigation?

The FDA product code for iFuse Implant System- iFuse Navigation is OLO.

Related Clinical Trials

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.

NCT05870488iFuse TORQ for the Treatment of Sacroiliac Joint DysfunctionACTIVE_NOT_RECRUITINGNCT07565545Posterior-Inferior Intra-articular Cortical Piercing Titanium Implant for Sacroiliac Joint Fusion: Evaluation of Safety and Effectiveness OutcomesNOT_YET_RECRUITINGNCT07530497Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring FracturesRECRUITING

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 SystemK232800Navigation Tracking Instruments

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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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