FDA 510(k)

CD HORIZON Fenestrated Screw Set

K-Number: K170347 · 2017-04-04

Decision Date2017-04-04

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

CD HORIZON Fenestrated Screw Set is a medical device manufactured by Medtronic Sofamor Danek USA. It received FDA 510(k) clearance on 2017-04-04 under approval number K170347. 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 CD HORIZON Fenestrated Screw Set?

CD HORIZON Fenestrated Screw Set is a medical device that received FDA 510(k) clearance on 2017-04-04. It is manufactured by Medtronic Sofamor Danek USA. The 510(k) number is K170347.

When was CD HORIZON Fenestrated Screw Set approved by the FDA?

CD HORIZON Fenestrated Screw Set received FDA 510(k) clearance on 2017-04-04, under approval number K170347.

What company makes CD HORIZON Fenestrated Screw Set?

CD HORIZON Fenestrated Screw Set is manufactured by Medtronic Sofamor Danek USA.

What is the FDA product code for CD HORIZON Fenestrated Screw Set?

The FDA product code for CD HORIZON Fenestrated Screw Set is NKB.

Other Devices by Medtronic Sofamor Danek USA

K214010Anteralign Spinal System with Titan nanoLOCK Surface Technology

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.