The Solstice OCT System
K-Number: K170804 · 2017-05-18
ApplicantLife Spine, Inc.
Decision Date2017-05-18
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 2017-05-18 under approval number K170804. 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 2017-05-18. It is manufactured by Life Spine, Inc.. The 510(k) number is K170804.
When was The Solstice OCT System approved by the FDA?
The Solstice OCT System received FDA 510(k) clearance on 2017-05-18, under approval number K170804.
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.
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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.