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FDA 510(k)

TranS1 AxiaLIF Plus System

K-Number: K192792 · 2019-11-20

ApplicantTrans1
Decision Date2019-11-20
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TranS1 AxiaLIF Plus System is a medical device manufactured by Trans1. It received FDA 510(k) clearance on 2019-11-20 under approval number K192792. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TranS1 AxiaLIF Plus System?

TranS1 AxiaLIF Plus System is a medical device that received FDA 510(k) clearance on 2019-11-20. It is manufactured by Trans1. The 510(k) number is K192792.

When was TranS1 AxiaLIF Plus System approved by the FDA?

TranS1 AxiaLIF Plus System received FDA 510(k) clearance on 2019-11-20, under approval number K192792.

What company makes TranS1 AxiaLIF Plus System?

TranS1 AxiaLIF Plus System is manufactured by Trans1.

What is the FDA product code for TranS1 AxiaLIF Plus System?

The FDA product code for TranS1 AxiaLIF Plus System is KWQ.

Other Devices by Trans1

K191791TranS1 Interbody Fusion System

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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.

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