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FDA 510(k)

FaSet Fixation System

K-Number: K222515 · 2022-10-05

ApplicantDio Medical Corporation
Decision Date2022-10-05
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

FaSet 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 2022-10-05 under 510(k) number K222515. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FaSet Fixation System?

FaSet Fixation System is a medical device that received FDA 510(k) clearance on 2022-10-05. The listed applicant is Dio Medical Corporation. The 510(k) number is K222515.

When did FaSet Fixation System receive FDA 510(k) clearance?

FaSet Fixation System received FDA 510(k) clearance on 2022-10-05, under 510(k) number K222515.

Who is the listed applicant for FaSet 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 FaSet Fixation System?

The FDA product code for FaSet Fixation System is MRW.

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 SystemK222448UNITY Sacroiliac Joint Fixation SystemK162849Huvex Interspinous Fixation System

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Related Devices (Code: MRW)

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.

K261209Ion-LSurGenTec, LLCK253676CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)Providence Medical Technology, Inc.K253432DiversiVy™ Facet Screw SystemVy Spine, LLCK251714Ion-CSurGenTec, LLCK250679FFX Facet Fixation SystemSc MedicaK253190CORUS-LX ImplantProvidence Medical Technology, Inc.

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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