FDA 510(k)

APOLLO Anterior Cervical Plate (ACP) System

K-Number: K210325 · 2021-03-23

Decision Date2021-03-23

Product CodeKWQ

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

APOLLO Anterior Cervical Plate (ACP) System is a medical device manufactured by Aurora Spine, Inc.. It received FDA 510(k) clearance on 2021-03-23 under approval number K210325. 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 APOLLO Anterior Cervical Plate (ACP) System?

APOLLO Anterior Cervical Plate (ACP) System is a medical device that received FDA 510(k) clearance on 2021-03-23. It is manufactured by Aurora Spine, Inc.. The 510(k) number is K210325.

When was APOLLO Anterior Cervical Plate (ACP) System approved by the FDA?

APOLLO Anterior Cervical Plate (ACP) System received FDA 510(k) clearance on 2021-03-23, under approval number K210325.

What company makes APOLLO Anterior Cervical Plate (ACP) System?

APOLLO Anterior Cervical Plate (ACP) System is manufactured by Aurora Spine, Inc..

What is the FDA product code for APOLLO Anterior Cervical Plate (ACP) System?

The FDA product code for APOLLO Anterior Cervical Plate (ACP) System is KWQ.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.