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)

Velofix TLIF Cage

K-Number: K181829 · 2018-11-14

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.

Other Devices by U&I Corporation

View all 16 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.