Yukon OCT Spinal System
K-Number: K193129 · 2020-02-07
ApplicantK2m, Inc.
Decision Date2020-02-07
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Yukon OCT Spinal System is a medical device manufactured by K2m, Inc.. It received FDA 510(k) clearance on 2020-02-07 under approval number K193129. 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 Yukon OCT Spinal System?
Yukon OCT Spinal System is a medical device that received FDA 510(k) clearance on 2020-02-07. It is manufactured by K2m, Inc.. The 510(k) number is K193129.
When was Yukon OCT Spinal System approved by the FDA?
Yukon OCT Spinal System received FDA 510(k) clearance on 2020-02-07, under approval number K193129.
What company makes Yukon OCT Spinal System?
Yukon OCT Spinal System is manufactured by K2m, Inc..
What is the FDA product code for Yukon OCT Spinal System?
The FDA product code for Yukon OCT Spinal 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.