Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Vail ALIF Buttress Plate System

K-Number: K180755 · 2018-07-06

ApplicantEvolution Spine, LLC
Decision Date2018-07-06
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Vail ALIF Buttress Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Evolution Spine, LLC. It received FDA 510(k) clearance on 2018-07-06 under 510(k) number K180755. 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 Vail ALIF Buttress Plate System?

Vail ALIF Buttress Plate System is a medical device that received FDA 510(k) clearance on 2018-07-06. The listed applicant is Evolution Spine, LLC. The 510(k) number is K180755.

When did Vail ALIF Buttress Plate System receive FDA 510(k) clearance?

Vail ALIF Buttress Plate System received FDA 510(k) clearance on 2018-07-06, under 510(k) number K180755.

Who is the listed applicant for Vail ALIF Buttress Plate System?

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

What is the FDA product code for Vail ALIF Buttress Plate System?

The FDA product code for Vail ALIF Buttress Plate System is KWQ.

Other records listing Evolution 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.

K262094E3D™-C Interbody SystemK260038E3D™-C Interbody SystemK250167Evolution Spine Navigation InstrumentsK241846E3D™-C Interbody SystemK240368E3D™-A Interbody SystemK232432E3D™-A Interbody System

View all 14 devices →

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.

↑