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FDA 510(k)

Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System)

K-Number: K181549 · 2018-08-03

ApplicantCuriteva, LLC
Decision Date2018-08-03
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System) is the device name listed in this FDA 510(k) record. The listed applicant is Curiteva, LLC. It received FDA 510(k) clearance on 2018-08-03 under 510(k) number K181549. 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 Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System)?

Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System) is a medical device that received FDA 510(k) clearance on 2018-08-03. The listed applicant is Curiteva, LLC. The 510(k) number is K181549.

When did Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System) receive FDA 510(k) clearance?

Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System) received FDA 510(k) clearance on 2018-08-03, under 510(k) number K181549.

Who is the listed applicant for Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System)?

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

What is the FDA product code for Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System)?

The FDA product code for Curiteva Midline Anterior Cervical Plate System (or Curiteva 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 Curiteva, 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.

K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF SystemK254061Curiteva Porous PEEK Cervical Interbody Fusion SystemK250845Curiteva Porous PEEK Standalone ALIF SystemK243137Curiteva Porous PEEK Laminoplasty SystemK233360Curiteva Thoracolumbar Plate SystemK233744Curiteva Porous PEEK Lumbar Interbody Fusion System

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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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