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FDA 510(k)

AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF II

K-Number: K092124 · 2010-01-21

ApplicantTrans1 Incorporated
Decision Date2010-01-21
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF II is the device name listed in this FDA 510(k) record. The listed applicant is Trans1 Incorporated. It received FDA 510(k) clearance on 2010-01-21 under 510(k) number K092124. 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 AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF II?

AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF II is a medical device that received FDA 510(k) clearance on 2010-01-21. The listed applicant is Trans1 Incorporated. The 510(k) number is K092124.

When did AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF II receive FDA 510(k) clearance?

AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF II received FDA 510(k) clearance on 2010-01-21, under 510(k) number K092124.

Who is the listed applicant for AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF II?

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 AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF II?

The FDA product code for AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF II 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 SYSTEMK102334TRANS1 AXIALIF PLUSK100210TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, TK073643TRANS1 AXIALIF 2-LEVEL OR II SYSTEMK073515TRANS1 FACET SCREWK073514TRANS1 AXIAL FIXATON SYSTEM

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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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