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FDA 510(k)

Cure™ OPEL-C Plate System

K-Number: K181543 · 2018-08-31

ApplicantMeditech Spine, LLC
Decision Date2018-08-31
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Cure™ OPEL-C Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Meditech Spine, LLC. It received FDA 510(k) clearance on 2018-08-31 under 510(k) number K181543. 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™ OPEL-C Plate System?

Cure™ OPEL-C Plate System is a medical device that received FDA 510(k) clearance on 2018-08-31. The listed applicant is Meditech Spine, LLC. The 510(k) number is K181543.

When did Cure™ OPEL-C Plate System receive FDA 510(k) clearance?

Cure™ OPEL-C Plate System received FDA 510(k) clearance on 2018-08-31, under 510(k) number K181543.

Who is the listed applicant for Cure™ OPEL-C Plate System?

The FDA 510(k) record lists Meditech Spine, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cure™ OPEL-C Plate System?

The FDA product code for Cure™ OPEL-C Plate System is KWQ.

Other records listing Meditech Spine, LLC 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.

K210286Cure 2.0 Anterior Cervical Plate (ACP) SystemK201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion SystemK201136Cure™ Lumbar Plate SystemK180090Cure™ Lumbar Plate SystemK171538Cure™ Lumbar Plate SystemK170395Talos® Lumbar (HA) PEEK IBF Devices

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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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