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FDA 510(k)

Sapphire X3 Anterior Cervical Plate System

K-Number: K231593 · 2023-08-02

ApplicantSpinal Elements, Inc.
Decision Date2023-08-02
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Sapphire X3 Anterior Cervical Plate System is a medical device manufactured by Spinal Elements, Inc.. It received FDA 510(k) clearance on 2023-08-02 under approval number K231593. 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 Sapphire X3 Anterior Cervical Plate System?

Sapphire X3 Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2023-08-02. It is manufactured by Spinal Elements, Inc.. The 510(k) number is K231593.

When was Sapphire X3 Anterior Cervical Plate System approved by the FDA?

Sapphire X3 Anterior Cervical Plate System received FDA 510(k) clearance on 2023-08-02, under approval number K231593.

What company makes Sapphire X3 Anterior Cervical Plate System?

Sapphire X3 Anterior Cervical Plate System is manufactured by Spinal Elements, Inc..

What is the FDA product code for Sapphire X3 Anterior Cervical Plate System?

The FDA product code for Sapphire X3 Anterior Cervical Plate System is KWQ.

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Other Devices by Spinal Elements, Inc.

K153352Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody System K160465Spinal Elements' Spinous Process Plate System K152011Lucent Intervertebral Body Fusion Device K170235Lucent® K182584Lucent® XP K181837Spinal Elements Ti-Bond coated devices

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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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