FDA 510(k)

Salvo Spine System

K-Number: K191045 · 2019-07-10

Decision Date2019-07-10

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 2019-07-10 under approval number K191045. 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 2019-07-10. It is manufactured by Spine Wave, Inc.. The 510(k) number is K191045.

When was Salvo Spine System approved by the FDA?

Salvo Spine System received FDA 510(k) clearance on 2019-07-10, under approval number K191045.

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.

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Other Devices by Spine Wave, Inc.

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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.