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FDA 510(k)

TRANS1 AXIALIF PLUS

K-Number: K102334 · 2011-03-14

ApplicantTrans1 Incorporated
Decision Date2011-03-14
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRANS1 AXIALIF PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Trans1 Incorporated. It received FDA 510(k) clearance on 2011-03-14 under 510(k) number K102334. 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?

TRANS1 AXIALIF PLUS is a medical device that received FDA 510(k) clearance on 2011-03-14. The listed applicant is Trans1 Incorporated. The 510(k) number is K102334.

When did TRANS1 AXIALIF PLUS receive FDA 510(k) clearance?

TRANS1 AXIALIF PLUS received FDA 510(k) clearance on 2011-03-14, under 510(k) number K102334.

Who is the listed applicant for TRANS1 AXIALIF PLUS?

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

What is the FDA product code for TRANS1 AXIALIF PLUS?

The FDA product code for TRANS1 AXIALIF PLUS is KWQ.

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Other records listing Trans1 Incorporated 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.

K120991TRANS1 INTERBODY FUSION SYSTEMK100210TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, TK092124AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF IIK073643TRANS1 AXIALIF 2-LEVEL OR II SYSTEMK073515TRANS1 FACET SCREWK073514TRANS1 AXIAL FIXATON SYSTEM

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Related Devices (Code: KWQ)

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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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