ANAX OCT Spinal System
K-Number: K183383 · 2018-12-12
ApplicantU&I Corporation
Decision Date2018-12-12
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
ANAX OCT Spinal System is a medical device manufactured by U&I Corporation. It received FDA 510(k) clearance on 2018-12-12 under approval number K183383. 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 ANAX OCT Spinal System?
ANAX OCT Spinal System is a medical device that received FDA 510(k) clearance on 2018-12-12. It is manufactured by U&I Corporation. The 510(k) number is K183383.
When was ANAX OCT Spinal System approved by the FDA?
ANAX OCT Spinal System received FDA 510(k) clearance on 2018-12-12, under approval number K183383.
What company makes ANAX OCT Spinal System?
ANAX OCT Spinal System is manufactured by U&I Corporation.
What is the FDA product code for ANAX OCT Spinal System?
The FDA product code for ANAX 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.