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)

Xenco Medical Multilevel CerviKit

K-Number: K213456 · 2021-12-21

ApplicantXenco Medical, LLC
Decision Date2021-12-21
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Xenco Medical Multilevel CerviKit is a medical device manufactured by Xenco Medical, LLC. It received FDA 510(k) clearance on 2021-12-21 under approval number K213456. 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 Xenco Medical Multilevel CerviKit?

Xenco Medical Multilevel CerviKit is a medical device that received FDA 510(k) clearance on 2021-12-21. It is manufactured by Xenco Medical, LLC. The 510(k) number is K213456.

When was Xenco Medical Multilevel CerviKit approved by the FDA?

Xenco Medical Multilevel CerviKit received FDA 510(k) clearance on 2021-12-21, under approval number K213456.

What company makes Xenco Medical Multilevel CerviKit?

Xenco Medical Multilevel CerviKit is manufactured by Xenco Medical, LLC.

What is the FDA product code for Xenco Medical Multilevel CerviKit?

The FDA product code for Xenco Medical Multilevel CerviKit is KWQ.

Other Devices by Xenco Medical, LLC

K160313Xenco Medical Cervical Interbody System K161478Xenco Medical Posterior Cervical System K160986Xenco Medical Pedicle Screw System K170611SETx Pedicle Screw System K173933Sorrento Bioglass Bone Graft Substitute K180373CancelleX Porous Titanium Lumbar Interbody Device

View all 11 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.

↑