NuVasive® TLX Interbody System
K-Number: K153627 · 2016-03-17
ApplicantNu Vasive, Incorporated
Decision Date2016-03-17
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
NuVasive® TLX Interbody System is a medical device manufactured by Nu Vasive, Incorporated. It received FDA 510(k) clearance on 2016-03-17 under approval number K153627. 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 NuVasive® TLX Interbody System?
NuVasive® TLX Interbody System is a medical device that received FDA 510(k) clearance on 2016-03-17. It is manufactured by Nu Vasive, Incorporated. The 510(k) number is K153627.
When was NuVasive® TLX Interbody System approved by the FDA?
NuVasive® TLX Interbody System received FDA 510(k) clearance on 2016-03-17, under approval number K153627.
What company makes NuVasive® TLX Interbody System?
NuVasive® TLX Interbody System is manufactured by Nu Vasive, Incorporated.
What is the FDA product code for NuVasive® TLX Interbody System?
The FDA product code for NuVasive® TLX Interbody System is MAX.
Related Clinical Trials
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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.