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FDA 510(k)

Axis Anterior Cervical Plate System

K-Number: K173867 · 2018-04-05

ApplicantAxis Orthopaedics
Decision Date2018-04-05
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Axis Anterior Cervical Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Axis Orthopaedics. It received FDA 510(k) clearance on 2018-04-05 under 510(k) number K173867. 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 Axis Anterior Cervical Plate System?

Axis Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2018-04-05. The listed applicant is Axis Orthopaedics. The 510(k) number is K173867.

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

Axis Anterior Cervical Plate System received FDA 510(k) clearance on 2018-04-05, under 510(k) number K173867.

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

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

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

The FDA product code for Axis 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 Axis Orthopaedics 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.

K181140Axis Chena Cervical PEEK Spacer SystemK180301AXIS 5.5 Lumbar Pedicle Screw 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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