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FDA 510(k)

ARENAL Anterior Cervical Plate System

K-Number: K240935 · 2024-05-17

ApplicantEffortmed, LLC
Decision Date2024-05-17
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARENAL Anterior Cervical Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Effortmed, LLC. It received FDA 510(k) clearance on 2024-05-17 under 510(k) number K240935. 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 ARENAL Anterior Cervical Plate System?

ARENAL Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2024-05-17. The listed applicant is Effortmed, LLC. The 510(k) number is K240935.

When did ARENAL Anterior Cervical Plate System receive FDA 510(k) clearance?

ARENAL Anterior Cervical Plate System received FDA 510(k) clearance on 2024-05-17, under 510(k) number K240935.

Who is the listed applicant for ARENAL Anterior Cervical Plate System?

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

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

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

Related Clinical Trials

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.

NCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATION

Other records listing Effortmed, 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.

K252686EffortMed PEEK Cages & Corpectomy CagesK243946EffortMed Spinal Fixation System

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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