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FDA 510(k)

SILO TFX MIS Sacroiliac Joint Fixation System

K-Number: K221047 · 2022-10-03

ApplicantAurora Spine, Inc.
Decision Date2022-10-03
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SILO TFX MIS Sacroiliac Joint Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Aurora Spine, Inc.. It received FDA 510(k) clearance on 2022-10-03 under 510(k) number K221047. 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 SILO TFX MIS Sacroiliac Joint Fixation System?

SILO TFX MIS Sacroiliac Joint Fixation System is a medical device that received FDA 510(k) clearance on 2022-10-03. The listed applicant is Aurora Spine, Inc.. The 510(k) number is K221047.

When did SILO TFX MIS Sacroiliac Joint Fixation System receive FDA 510(k) clearance?

SILO TFX MIS Sacroiliac Joint Fixation System received FDA 510(k) clearance on 2022-10-03, under 510(k) number K221047.

Who is the listed applicant for SILO TFX MIS Sacroiliac Joint Fixation System?

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

What is the FDA product code for SILO TFX MIS Sacroiliac Joint Fixation System?

The FDA product code for SILO TFX MIS Sacroiliac Joint Fixation 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.

NCT05367505Titanium Fusion Implant in Combination With Trans-iliac Screws for Insufficiency Fractures of the PelvisACTIVE_NOT_RECRUITING

Other records listing Aurora Spine, 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.

K243865AERO MIS Facet Fusion SystemK221399ZIP™ MIS Interspinous Fusion SystemK220610SOLO-LK210521DEXA-C Cervical Interbody SystemK210325APOLLO Anterior Cervical Plate (ACP) System

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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