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FDA 510(k)

Omnia Medical VBR

K-Number: K191778 · 2019-08-28

ApplicantOmnia Medical, LLC
Decision Date2019-08-28
Product CodePLR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Omnia Medical VBR is the device name listed in this FDA 510(k) record. The listed applicant is Omnia Medical, LLC. It received FDA 510(k) clearance on 2019-08-28 under 510(k) number K191778. The device is classified under product code PLR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Omnia Medical VBR?

Omnia Medical VBR is a medical device that received FDA 510(k) clearance on 2019-08-28. The listed applicant is Omnia Medical, LLC. The 510(k) number is K191778.

When did Omnia Medical VBR receive FDA 510(k) clearance?

Omnia Medical VBR received FDA 510(k) clearance on 2019-08-28, under 510(k) number K191778.

Who is the listed applicant for Omnia Medical VBR?

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

What is the FDA product code for Omnia Medical VBR?

The FDA product code for Omnia Medical VBR is PLR.

Other records listing Omnia Medical, LLC as applicant

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K242431Omnia Medical PsiF DNA™ SystemK240623Omnia Medical TiBrid™-SA SystemK230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral Lumbar Plate SystemK223321Omnia Medical Coupler-C Anterior Cervical PlateK212612Omnia Medical TiBrid-SCK203207Omnia Medical TiBrid-SA

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Related Devices (Code: PLR)

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.

K252822Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy ImplantAtlas Spine, Inc.K252560Atlas Spine HiRISE™ Expandable Cervical Corpectomy SystemAtlas Spine, Inc.K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLCK221542Galileo Vertebral Body Replacement DeviceBright SpineK212126MediExpand Cervical Expandable VBR SystemCmf Medicon Surgical, Inc.K211320CAPRI Corpectomy Cage SystemK2m, 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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