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FDA 510(k)

Vitality® Spinal Fixation System, Vitality®+ Power Instrument System

K-Number: K172275 · 2017-09-27

ApplicantZimmer Biomet Spine, Inc.
Decision Date2017-09-27
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Vitality® Spinal Fixation System, Vitality®+ Power Instrument System is a medical device manufactured by Zimmer Biomet Spine, Inc.. It received FDA 510(k) clearance on 2017-09-27 under approval number K172275. 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 Vitality® Spinal Fixation System, Vitality®+ Power Instrument System?

Vitality® Spinal Fixation System, Vitality®+ Power Instrument System is a medical device that received FDA 510(k) clearance on 2017-09-27. It is manufactured by Zimmer Biomet Spine, Inc.. The 510(k) number is K172275.

When was Vitality® Spinal Fixation System, Vitality®+ Power Instrument System approved by the FDA?

Vitality® Spinal Fixation System, Vitality®+ Power Instrument System received FDA 510(k) clearance on 2017-09-27, under approval number K172275.

What company makes Vitality® Spinal Fixation System, Vitality®+ Power Instrument System?

Vitality® Spinal Fixation System, Vitality®+ Power Instrument System is manufactured by Zimmer Biomet Spine, Inc..

What is the FDA product code for Vitality® Spinal Fixation System, Vitality®+ Power Instrument System?

The FDA product code for Vitality® Spinal Fixation System, Vitality®+ Power Instrument System is NKB.

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Related PubMed Literature

PMID: 35685299 Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). Journal of pain research (2022)

Other Devices by Zimmer Biomet Spine, Inc.

K171907Vitality® Spinal Fixation System K163543Biomet Fusion System K180227Polaris Spinal Growth System K171495Zyston Strut Open Titanium Spacer System K191722Vital Navigation System K192133Zimmer Biomet Universal Navigation System

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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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