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FDA 510(k)

UNITY Sacroiliac Joint Fixation System

K-Number: K222448 · 2022-10-13

ApplicantDio Medical Corporation
Decision Date2022-10-13
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UNITY Sacroiliac Joint Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Dio Medical Corporation. It received FDA 510(k) clearance on 2022-10-13 under 510(k) number K222448. 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 UNITY Sacroiliac Joint Fixation System?

UNITY Sacroiliac Joint Fixation System is a medical device that received FDA 510(k) clearance on 2022-10-13. The listed applicant is Dio Medical Corporation. The 510(k) number is K222448.

When did UNITY Sacroiliac Joint Fixation System receive FDA 510(k) clearance?

UNITY Sacroiliac Joint Fixation System received FDA 510(k) clearance on 2022-10-13, under 510(k) number K222448.

Who is the listed applicant for UNITY Sacroiliac Joint Fixation System?

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

What is the FDA product code for UNITY Sacroiliac Joint Fixation System?

The FDA product code for UNITY 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 Dio Medical Corporation 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.

K223790Huvex Interspinous Fusion SystemK223140AEON-C™ Stand Alone SystemK222415Rexious Spinal Fixation SystemK222572FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar Plate SystemK222515FaSet Fixation SystemK162849Huvex Interspinous 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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