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FDA 510(k)

Velofix™ TLIF Cage

K-Number: K172419 · 2017-12-04

Decision Date2017-12-04
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 2017-12-04 under approval number K172419. 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 2017-12-04. It is manufactured by U&I Corporation. The 510(k) number is K172419.

When was Velofix™ TLIF Cage approved by the FDA?

Velofix™ TLIF Cage received FDA 510(k) clearance on 2017-12-04, under approval number K172419.

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

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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.