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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 the device name listed in this FDA 510(k) record. The listed applicant is Spinal Elements, Inc.. It received FDA 510(k) clearance on 2020-06-17 under 510(k) 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. The listed applicant is Spinal Elements, Inc.. The 510(k) number is K201029.

When did Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System receive FDA 510(k) clearance?

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

Who is the listed applicant for Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System?

The FDA 510(k) record lists Spinal Elements, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATIONNCT06938607Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain PlacementNOT_YET_RECRUITING

Other records listing Spinal Elements, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: KWQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLCK252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLCK260015ANTERIS Thoracolumbar Plate SystemSpineCraft

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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