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FDA 510(k)

TRANS1 AXIALIF SYSTEM

K-Number: K050965 · 2005-06-14

ApplicantTrans1 Incorporated
Decision Date2005-06-14
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRANS1 AXIALIF SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Trans1 Incorporated. It received FDA 510(k) clearance on 2005-06-14 under 510(k) number K050965. 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 SYSTEM?

TRANS1 AXIALIF SYSTEM is a medical device that received FDA 510(k) clearance on 2005-06-14. The listed applicant is Trans1 Incorporated. The 510(k) number is K050965.

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

TRANS1 AXIALIF SYSTEM received FDA 510(k) clearance on 2005-06-14, under 510(k) number K050965.

Who is the listed applicant for TRANS1 AXIALIF SYSTEM?

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 SYSTEM?

The FDA product code for TRANS1 AXIALIF SYSTEM 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, TK092124AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF IIK073643TRANS1 AXIALIF 2-LEVEL OR II SYSTEMK073515TRANS1 FACET SCREW

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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.

K262149corra® cervical plating systemCarlsmed, Inc.K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLCK252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC

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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