FDA 510(k)

EMERGE Anterior Cervical Plate System

K-Number: K212405 · 2021-09-30

Decision Date2021-09-30

Product CodeKWQ

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

EMERGE Anterior Cervical Plate System is a medical device manufactured by Evolution Spine. It received FDA 510(k) clearance on 2021-09-30 under approval number K212405. 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 EMERGE Anterior Cervical Plate System?

EMERGE Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2021-09-30. It is manufactured by Evolution Spine. The 510(k) number is K212405.

When was EMERGE Anterior Cervical Plate System approved by the FDA?

EMERGE Anterior Cervical Plate System received FDA 510(k) clearance on 2021-09-30, under approval number K212405.

What company makes EMERGE Anterior Cervical Plate System?

EMERGE Anterior Cervical Plate System is manufactured by Evolution Spine.

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

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

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Other Devices by Evolution Spine

K220275EMERGE Anterior Cervical Plate System K223146EVOLUTION SPINE Interbody System K241846E3D-C Interbody System K240368E3D-A Interbody System K232432E3D-A Interbody System K250167Evolution Spine Navigation Instruments

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Related Devices (Code: KWQ)

K160982SphynxEden 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.