FDA 510(k)

ANAX 5.5 Spinal System

K-Number: K173524 · 2017-12-13

Decision Date2017-12-13

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ANAX 5.5 Spinal System is a medical device manufactured by U&I Corporation. It received FDA 510(k) clearance on 2017-12-13 under approval number K173524. 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 ANAX 5.5 Spinal System?

ANAX 5.5 Spinal System is a medical device that received FDA 510(k) clearance on 2017-12-13. It is manufactured by U&I Corporation. The 510(k) number is K173524.

When was ANAX 5.5 Spinal System approved by the FDA?

ANAX 5.5 Spinal System received FDA 510(k) clearance on 2017-12-13, under approval number K173524.

What company makes ANAX 5.5 Spinal System?

ANAX 5.5 Spinal System is manufactured by U&I Corporation.

What is the FDA product code for ANAX 5.5 Spinal System?

The FDA product code for ANAX 5.5 Spinal System is NKB.

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Related PubMed Literature

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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.