FDA 510(k)

Expedium Spine System, VIPER and VIPER 2 Systems

K-Number: K160904 · 2016-07-01

Decision Date2016-07-01

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Expedium Spine System, VIPER and VIPER 2 Systems is a medical device manufactured by Medos International SARL. It received FDA 510(k) clearance on 2016-07-01 under approval number K160904. 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 Expedium Spine System, VIPER and VIPER 2 Systems?

Expedium Spine System, VIPER and VIPER 2 Systems is a medical device that received FDA 510(k) clearance on 2016-07-01. It is manufactured by Medos International SARL. The 510(k) number is K160904.

When was Expedium Spine System, VIPER and VIPER 2 Systems approved by the FDA?

Expedium Spine System, VIPER and VIPER 2 Systems received FDA 510(k) clearance on 2016-07-01, under approval number K160904.

What company makes Expedium Spine System, VIPER and VIPER 2 Systems?

Expedium Spine System, VIPER and VIPER 2 Systems is manufactured by Medos International SARL.

What is the FDA product code for Expedium Spine System, VIPER and VIPER 2 Systems?

The FDA product code for Expedium Spine System, VIPER and VIPER 2 Systems is NKB.

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Other Devices by Medos International SARL

K162247PERMATAPE K162327COUGAR® LS Lateral Cage System and COUGAR® System K162912VIPER PRIME additions to the VIPER® System K163106CODMAN Integrated Bipolar Cord and Tubing Set K161638SPEEDTRAP Graft Preparation System K162469CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps, CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.