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FDA 510(k)

STRUXXURE®-L and STRUXXURE®-A Plate System

K-Number: K202192 · 2020-09-17

ApplicantNexxt Spine, LLC
Decision Date2020-09-17
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STRUXXURE®-L and STRUXXURE®-A Plate System is a medical device manufactured by Nexxt Spine, LLC. It received FDA 510(k) clearance on 2020-09-17 under approval number K202192. 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 STRUXXURE®-L and STRUXXURE®-A Plate System?

STRUXXURE®-L and STRUXXURE®-A Plate System is a medical device that received FDA 510(k) clearance on 2020-09-17. It is manufactured by Nexxt Spine, LLC. The 510(k) number is K202192.

When was STRUXXURE®-L and STRUXXURE®-A Plate System approved by the FDA?

STRUXXURE®-L and STRUXXURE®-A Plate System received FDA 510(k) clearance on 2020-09-17, under approval number K202192.

What company makes STRUXXURE®-L and STRUXXURE®-A Plate System?

STRUXXURE®-L and STRUXXURE®-A Plate System is manufactured by Nexxt Spine, LLC.

What is the FDA product code for STRUXXURE®-L and STRUXXURE®-A Plate System?

The FDA product code for STRUXXURE®-L and STRUXXURE®-A Plate System is KWQ.

Related Clinical Trials

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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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