Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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 a medical device manufactured by Evolution Spine, LLC. It received FDA 510(k) clearance on 2018-07-06 under approval 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. It is manufactured by Evolution Spine, LLC. The 510(k) number is K180755.

When was Vail ALIF Buttress Plate System approved by the FDA?

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

What company makes Vail ALIF Buttress Plate System?

Vail ALIF Buttress Plate System is manufactured by Evolution Spine, LLC.

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

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

Related Clinical Trials

NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT06409559 Rim Plate to Buttress Plate for Posterior Wall Acetabular Fractures With and Without Inter-fragmentary Screws RECRUITING

Other Devices by Evolution Spine, LLC

K160663Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF) K160324Cervical Interbody Fusion System K173375Anterior Cervical Plate System K182478Whistler Modular Pedicle Screw System

Related Devices (Code: KWQ)

K160982Sphynx™Eden Spine, LLC K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc. K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA K162211AccuFit Lateral Plate SystemPrecision Spine, Inc. K162250FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC K162664Pyrenees Cervical Plate SystemK2m, Inc.

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.

↑