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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 the device name listed in this FDA 510(k) record. The listed applicant is Trans1. It received FDA 510(k) clearance on 2019-11-20 under 510(k) 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. The listed applicant is Trans1. The 510(k) number is K192792.

When did TranS1 AxiaLIF Plus System receive FDA 510(k) clearance?

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

Who is the listed applicant for TranS1 AxiaLIF Plus System?

The FDA 510(k) record lists Trans1 as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Trans1 as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K191791TranS1 Interbody Fusion System

Related Devices (Code: KWQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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