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FDA 510(k)

Salvo® Spine System

K-Number: K222362 · 2022-08-29

ApplicantSpine Wave, Inc.
Decision Date2022-08-29
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Salvo® Spine System is a medical device manufactured by Spine Wave, Inc.. It received FDA 510(k) clearance on 2022-08-29 under approval number K222362. 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 Salvo® Spine System?

Salvo® Spine System is a medical device that received FDA 510(k) clearance on 2022-08-29. It is manufactured by Spine Wave, Inc.. The 510(k) number is K222362.

When was Salvo® Spine System approved by the FDA?

Salvo® Spine System received FDA 510(k) clearance on 2022-08-29, under approval number K222362.

What company makes Salvo® Spine System?

Salvo® Spine System is manufactured by Spine Wave, Inc..

What is the FDA product code for Salvo® Spine System?

The FDA product code for Salvo® Spine System is NKB.

Related Clinical Trials

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Other Devices by Spine Wave, Inc.

K161993Leva® Anterior Interbody System K153222Leva Spacer System K160003Sniper (R) Spine System K152620Spine Wave Gen II Expandable Interbody System K172594Proficient® Posterior Cervical Spine System K173175Paramount Anterior Cervical Cage 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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