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FDA 510(k)

Omnia Medical PsiF DNA™ System

K-Number: K242431 · 2025-06-06

ApplicantOmnia Medical, LLC
Decision Date2025-06-06
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Omnia Medical PsiF DNA™ System is a medical device manufactured by Omnia Medical, LLC. It received FDA 510(k) clearance on 2025-06-06 under approval number K242431. 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 Omnia Medical PsiF DNA™ System?

Omnia Medical PsiF DNA™ System is a medical device that received FDA 510(k) clearance on 2025-06-06. It is manufactured by Omnia Medical, LLC. The 510(k) number is K242431.

When was Omnia Medical PsiF DNA™ System approved by the FDA?

Omnia Medical PsiF DNA™ System received FDA 510(k) clearance on 2025-06-06, under approval number K242431.

What company makes Omnia Medical PsiF DNA™ System?

Omnia Medical PsiF DNA™ System is manufactured by Omnia Medical, LLC.

What is the FDA product code for Omnia Medical PsiF DNA™ System?

The FDA product code for Omnia Medical PsiF DNA™ System is OUR.

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Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

Other Devices by Omnia Medical, LLC

K172323Omnia Medical VBR K191778Omnia Medical VBR K183659Omnia Medical Rotary PLIF System K203207Omnia Medical TiBrid-SA K192096Omnia Medical Trauma Screws K190363Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF Cage

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Related Devices (Code: OUR)

K161755Integrity-SI TM Fusion SystemCoorstek Medical K153656PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd. K161210RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) SystemsMedtronic Sofamor Danek K160652iFUSE Implant SystemSI-BONE, Inc. K152681iFuse Implant System(R)SI-BONE, Inc. K152237The Entasis Dual-Lead Sacroiliac ImplantCorelink, LLC

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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