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FDA 510(k)

Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System

K-Number: K201029 · 2020-06-17

ApplicantSpinal Elements, Inc.
Decision Date2020-06-17
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System is a medical device manufactured by Spinal Elements, Inc.. It received FDA 510(k) clearance on 2020-06-17 under approval number K201029. 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® Spinal System, Sapphire X Anterior Cervical Plate Spinal System?

Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System is a medical device that received FDA 510(k) clearance on 2020-06-17. It is manufactured by Spinal Elements, Inc.. The 510(k) number is K201029.

When was Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System approved by the FDA?

Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System received FDA 510(k) clearance on 2020-06-17, under approval number K201029.

What company makes Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System?

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

What is the FDA product code for Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System?

The FDA product code for Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System is KWQ.

Related Clinical Trials

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Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

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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