Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NuVasive TLX Interbody System

K-Number: K171633 · 2017-09-28

Decision Date2017-09-28
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 2017-09-28 under approval number K171633. 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 2017-09-28. It is manufactured by Nu Vasive, Incorporated. The 510(k) number is K171633.

When was NuVasive TLX Interbody System approved by the FDA?

NuVasive TLX Interbody System received FDA 510(k) clearance on 2017-09-28, under approval number K171633.

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

Other Devices by Nu Vasive, Incorporated

View all 79 devices →

Related Devices (Code: MAX)

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.