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FDA 510(k)

SI-BONE iFuse Implant System®

K-Number: K193524 · 2020-03-31

ApplicantSI-BONE, Inc.
Decision Date2020-03-31
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SI-BONE iFuse Implant System® 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 2020-03-31 under 510(k) number K193524. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SI-BONE iFuse Implant System®?

SI-BONE iFuse Implant System® is a medical device that received FDA 510(k) clearance on 2020-03-31. The listed applicant is SI-BONE, Inc.. The 510(k) number is K193524.

When did SI-BONE iFuse Implant System® receive FDA 510(k) clearance?

SI-BONE iFuse Implant System® received FDA 510(k) clearance on 2020-03-31, under 510(k) number K193524.

Who is the listed applicant for SI-BONE iFuse Implant System®?

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 SI-BONE iFuse Implant System®?

The FDA product code for SI-BONE iFuse Implant System® is OUR.

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_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 SystemK232800Navigation Tracking Instruments

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Related Devices (Code: OUR)

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.

K260477CATAMARAN™ SI Joint Fusion SystemTenon MedicalK253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.K253611Falco Fusion SystemMcnicoll Surgical, Inc.K252834Sacroiliac Joint Truss System (SJTS)4Web MedicalK251365OptumSI Implant SystemSi Solutions, LLCK252322SIros-X SystemGenesys Spine

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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