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FDA 510(k)

Cure™ Lumbar Plate System

K-Number: K171538 · 2017-06-16

ApplicantMeditech Spine, LLC
Decision Date2017-06-16
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Cure™ Lumbar 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 2017-06-16 under 510(k) number K171538. 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™ Lumbar Plate System?

Cure™ Lumbar Plate System is a medical device that received FDA 510(k) clearance on 2017-06-16. The listed applicant is Meditech Spine, LLC. The 510(k) number is K171538.

When did Cure™ Lumbar Plate System receive FDA 510(k) clearance?

Cure™ Lumbar Plate System received FDA 510(k) clearance on 2017-06-16, under 510(k) number K171538.

Who is the listed applicant for Cure™ Lumbar 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™ Lumbar Plate System?

The FDA product code for Cure™ Lumbar 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 SystemK181543Cure™ OPEL-C Plate SystemK180090Cure™ 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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