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)

Zavation Cervical Plate System

K-Number: K181244 · 2018-07-10

ApplicantZavation Medical Products, LLC
Decision Date2018-07-10
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Zavation Cervical Plate System is a medical device manufactured by Zavation Medical Products, LLC. It received FDA 510(k) clearance on 2018-07-10 under approval number K181244. 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 Zavation Cervical Plate System?

Zavation Cervical Plate System is a medical device that received FDA 510(k) clearance on 2018-07-10. It is manufactured by Zavation Medical Products, LLC. The 510(k) number is K181244.

When was Zavation Cervical Plate System approved by the FDA?

Zavation Cervical Plate System received FDA 510(k) clearance on 2018-07-10, under approval number K181244.

What company makes Zavation Cervical Plate System?

Zavation Cervical Plate System is manufactured by Zavation Medical Products, LLC.

What is the FDA product code for Zavation Cervical Plate System?

The FDA product code for Zavation Cervical Plate System is KWQ.

Related Clinical Trials

NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT05489822 PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. TERMINATED NCT07153536 Spinal Cord Stimulation Combined With Physical Therapy in Post-Stroke Upper-Limb Motor Hemiparesis RECRUITING NCT05305430 Real World Data Collection on the Synergy Cervical Disc RECRUITING NCT05880823 Post Market Data Collection Protocol to Evaluate the Performance of the Synergy Disc WITHDRAWN

Other Devices by Zavation Medical Products, LLC

K180076Ti 3Z Interbody System K180673Normandy VBR System K181246Zavation IBF System K180537Zavation Buttress Plate System K173752SI Screw System K173306EZ Plate

View all 30 devices →

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.

↑