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FDA 510(k)

Cure 2.0 Anterior Cervical Plate (ACP) System

K-Number: K210286 · 2021-03-18

ApplicantMeditech Spine, LLC
Decision Date2021-03-18
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Cure 2.0 Anterior Cervical Plate (ACP) System is a medical device manufactured by Meditech Spine, LLC. It received FDA 510(k) clearance on 2021-03-18 under approval number K210286. 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 Cure 2.0 Anterior Cervical Plate (ACP) System?

Cure 2.0 Anterior Cervical Plate (ACP) System is a medical device that received FDA 510(k) clearance on 2021-03-18. It is manufactured by Meditech Spine, LLC. The 510(k) number is K210286.

When was Cure 2.0 Anterior Cervical Plate (ACP) System approved by the FDA?

Cure 2.0 Anterior Cervical Plate (ACP) System received FDA 510(k) clearance on 2021-03-18, under approval number K210286.

What company makes Cure 2.0 Anterior Cervical Plate (ACP) System?

Cure 2.0 Anterior Cervical Plate (ACP) System is manufactured by Meditech Spine, LLC.

What is the FDA product code for Cure 2.0 Anterior Cervical Plate (ACP) System?

The FDA product code for Cure 2.0 Anterior Cervical Plate (ACP) System is KWQ.

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Other Devices by Meditech Spine, LLC

K160604Cure™ Anterior Cervical Plate (ACP) System K171538Cure™ Lumbar Plate System K170395Talos® Lumbar (HA) PEEK IBF Devices K181543Cure™ OPEL-C Plate System K180090Cure™ Lumbar Plate System K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System

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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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