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FDA 510(k)

iFuse Bedrock Granite Implant System

K-Number: K253094 · 2025-10-09

ApplicantSI-BONE, Inc.
Decision Date2025-10-09
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

iFuse Bedrock Granite 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 2025-10-09 under 510(k) number K253094. 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 iFuse Bedrock Granite Implant System?

iFuse Bedrock Granite Implant System is a medical device that received FDA 510(k) clearance on 2025-10-09. The listed applicant is SI-BONE, Inc.. The 510(k) number is K253094.

When did iFuse Bedrock Granite Implant System receive FDA 510(k) clearance?

iFuse Bedrock Granite Implant System received FDA 510(k) clearance on 2025-10-09, under 510(k) number K253094.

Who is the listed applicant for iFuse Bedrock Granite 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 iFuse Bedrock Granite Implant System?

The FDA product code for iFuse Bedrock Granite 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_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 SystemK251780iGPS Navigation InstrumentsK241504iFuse TORQ TNT™ Implant SystemK241574iFuse TORQ® Implant SystemK232800Navigation Tracking InstrumentsK233508iFuse Bedrock Granite® Implant System

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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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