Decision Date2018-11-14
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Velofix TLIF Cage is a medical device manufactured by U&I Corporation. It received FDA 510(k) clearance on 2018-11-14 under approval number K181829. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Velofix TLIF Cage?
Velofix TLIF Cage is a medical device that received FDA 510(k) clearance on 2018-11-14. It is manufactured by U&I Corporation. The 510(k) number is K181829.
When was Velofix TLIF Cage approved by the FDA?
Velofix TLIF Cage received FDA 510(k) clearance on 2018-11-14, under approval number K181829.
What company makes Velofix TLIF Cage?
Velofix TLIF Cage is manufactured by U&I Corporation.
What is the FDA product code for Velofix TLIF Cage?
The FDA product code for Velofix TLIF Cage is MAX.
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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.