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FDA 510(k)

Xenco Medical Pedicle Screw System

K-Number: K160986 · 2016-05-04

ApplicantXenco Medical, LLC
Decision Date2016-05-04
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Xenco Medical Pedicle Screw System is a medical device manufactured by Xenco Medical, LLC. It received FDA 510(k) clearance on 2016-05-04 under approval number K160986. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Xenco Medical Pedicle Screw System?

Xenco Medical Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2016-05-04. It is manufactured by Xenco Medical, LLC. The 510(k) number is K160986.

When was Xenco Medical Pedicle Screw System approved by the FDA?

Xenco Medical Pedicle Screw System received FDA 510(k) clearance on 2016-05-04, under approval number K160986.

What company makes Xenco Medical Pedicle Screw System?

Xenco Medical Pedicle Screw System is manufactured by Xenco Medical, LLC.

What is the FDA product code for Xenco Medical Pedicle Screw System?

The FDA product code for Xenco Medical Pedicle Screw System is NKB.

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Related PubMed Literature

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Other Devices by Xenco Medical, LLC

K160313Xenco Medical Cervical Interbody System K161478Xenco Medical Posterior Cervical System K170611SETx Pedicle Screw System K173933Sorrento Bioglass Bone Graft Substitute K180373CancelleX Porous Titanium Lumbar Interbody Device K191074Sorrento Bone Graft Substitute

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Related Devices (Code: NKB)

K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC K162912VIPER PRIME™ additions to the VIPER® SystemMedos International SARL K162160Preference Elite Pedicle Screw SystemAmedica Corporation K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, 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.

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