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FDA 510(k)

Omnia Medical Coupler-C Anterior Cervical Plate

K-Number: K223321 · 2023-03-13

ApplicantOmnia Medical, LLC
Decision Date2023-03-13
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Omnia Medical Coupler-C Anterior Cervical Plate is a medical device manufactured by Omnia Medical, LLC. It received FDA 510(k) clearance on 2023-03-13 under approval number K223321. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Omnia Medical Coupler-C Anterior Cervical Plate?

Omnia Medical Coupler-C Anterior Cervical Plate is a medical device that received FDA 510(k) clearance on 2023-03-13. It is manufactured by Omnia Medical, LLC. The 510(k) number is K223321.

When was Omnia Medical Coupler-C Anterior Cervical Plate approved by the FDA?

Omnia Medical Coupler-C Anterior Cervical Plate received FDA 510(k) clearance on 2023-03-13, under approval number K223321.

What company makes Omnia Medical Coupler-C Anterior Cervical Plate?

Omnia Medical Coupler-C Anterior Cervical Plate is manufactured by Omnia Medical, LLC.

What is the FDA product code for Omnia Medical Coupler-C Anterior Cervical Plate?

The FDA product code for Omnia Medical Coupler-C Anterior Cervical Plate is KWQ.

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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: KWQ)

K160982Sphynx™Eden Spine, LLC K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc. K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA K162211AccuFit Lateral Plate SystemPrecision Spine, Inc. K162250FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC K162664Pyrenees Cervical Plate 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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