ANAX 5.5 Spinal System
K-Number: K162189 · 2016-08-30
ApplicantU&I Corporation
Decision Date2016-08-30
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
ANAX 5.5 Spinal System is a medical device manufactured by U&I Corporation. It received FDA 510(k) clearance on 2016-08-30 under approval number K162189. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ANAX 5.5 Spinal System?
ANAX 5.5 Spinal System is a medical device that received FDA 510(k) clearance on 2016-08-30. It is manufactured by U&I Corporation. The 510(k) number is K162189.
When was ANAX 5.5 Spinal System approved by the FDA?
ANAX 5.5 Spinal System received FDA 510(k) clearance on 2016-08-30, under approval number K162189.
What company makes ANAX 5.5 Spinal System?
ANAX 5.5 Spinal System is manufactured by U&I Corporation.
What is the FDA product code for ANAX 5.5 Spinal System?
The FDA product code for ANAX 5.5 Spinal System is MNH. This falls under the ENT category.
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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.