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FDA 510(k)

Omnia Medical TiBrid-SA

K-Number: K203207 · 2020-12-23

ApplicantOmnia Medical, LLC
Decision Date2020-12-23
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Omnia Medical TiBrid-SA 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 2020-12-23 under 510(k) number K203207. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Omnia Medical TiBrid-SA?

Omnia Medical TiBrid-SA is a medical device that received FDA 510(k) clearance on 2020-12-23. The listed applicant is Omnia Medical, LLC. The 510(k) number is K203207.

When did Omnia Medical TiBrid-SA receive FDA 510(k) clearance?

Omnia Medical TiBrid-SA received FDA 510(k) clearance on 2020-12-23, under 510(k) number K203207.

Who is the listed applicant for Omnia Medical TiBrid-SA?

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 TiBrid-SA?

The FDA product code for Omnia Medical TiBrid-SA is OVD.

Other records listing Omnia Medical, LLC 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.

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-SCK192096Omnia Medical Trauma Screws

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Related Devices (Code: OVD)

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.

K261408SABER-XA SystemElevation SpineK261809Interwedge® Standalone LateralFoundation Surgical GroupK261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Anteralign LS coverplateTyber Medical, LLCK254202MectaLIF 3D Metal AnteriorMedacta International S.A.K253401SCRIPT™ Implant SystemGlobus Medical, 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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