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FDA 510(k)

Integrity-SI® Fusion System

K-Number: K230226 · 2023-09-21

ApplicantOsteoCentric Technologies
Decision Date2023-09-21
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Integrity-SI® Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is OsteoCentric Technologies. It received FDA 510(k) clearance on 2023-09-21 under 510(k) number K230226. 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 Integrity-SI® Fusion System?

Integrity-SI® Fusion System is a medical device that received FDA 510(k) clearance on 2023-09-21. The listed applicant is OsteoCentric Technologies. The 510(k) number is K230226.

When did Integrity-SI® Fusion System receive FDA 510(k) clearance?

Integrity-SI® Fusion System received FDA 510(k) clearance on 2023-09-21, under 510(k) number K230226.

Who is the listed applicant for Integrity-SI® Fusion System?

The FDA 510(k) record lists OsteoCentric Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Integrity-SI® Fusion System?

The FDA product code for Integrity-SI® Fusion System is OUR.

Other records listing OsteoCentric Technologies 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.

K250520OsteoCentric Navigated Instruments SystemK251913OsteoCentric® UnifiMI® TCS Plating SystemK250494The OsteoCentric Bone Plate and Screw SystemK242691OsteoCentric Technologies Cannulated Fasteners and NutsK230242OsteoCentric Dental Implant SystemK230595OsteoCentric ACL Fixation 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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