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FDA 510(k)

ADIRA™ Lateral Plate System

K-Number: K233735 · 2024-01-25

ApplicantGlobus Medical, Inc.
Decision Date2024-01-25
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ADIRA™ Lateral Plate System is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2024-01-25 under approval number K233735. 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 ADIRA™ Lateral Plate System?

ADIRA™ Lateral Plate System is a medical device that received FDA 510(k) clearance on 2024-01-25. It is manufactured by Globus Medical, Inc.. The 510(k) number is K233735.

When was ADIRA™ Lateral Plate System approved by the FDA?

ADIRA™ Lateral Plate System received FDA 510(k) clearance on 2024-01-25, under approval number K233735.

What company makes ADIRA™ Lateral Plate System?

ADIRA™ Lateral Plate System is manufactured by Globus Medical, Inc..

What is the FDA product code for ADIRA™ Lateral Plate System?

The FDA product code for ADIRA™ Lateral Plate System is KWQ.

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Other Devices by Globus Medical, Inc.

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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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