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FDA 510(k)

The Solstice OCT System

K-Number: K173047 · 2018-02-01

Decision Date2018-02-01
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

The Solstice OCT System is a medical device manufactured by Life Spine, Inc.. It received FDA 510(k) clearance on 2018-02-01 under approval number K173047. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The Solstice OCT System?

The Solstice OCT System is a medical device that received FDA 510(k) clearance on 2018-02-01. It is manufactured by Life Spine, Inc.. The 510(k) number is K173047.

When was The Solstice OCT System approved by the FDA?

The Solstice OCT System received FDA 510(k) clearance on 2018-02-01, under approval number K173047.

What company makes The Solstice OCT System?

The Solstice OCT System is manufactured by Life Spine, Inc..

What is the FDA product code for The Solstice OCT System?

The FDA product code for The Solstice OCT System is NKG.

Other Devices by Life Spine, Inc.

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Related Devices (Code: NKG)

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.