Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TRANS1 AXIAL FIXATION SYSTEM

K-Number: K040426 · 2004-12-17

ApplicantTrans1, Inc.
Decision Date2004-12-17
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRANS1 AXIAL FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Trans1, Inc.. It received FDA 510(k) clearance on 2004-12-17 under 510(k) number K040426. 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 AXIAL FIXATION SYSTEM?

TRANS1 AXIAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2004-12-17. The listed applicant is Trans1, Inc.. The 510(k) number is K040426.

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

TRANS1 AXIAL FIXATION SYSTEM received FDA 510(k) clearance on 2004-12-17, under 510(k) number K040426.

Who is the listed applicant for TRANS1 AXIAL FIXATION SYSTEM?

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

What is the FDA product code for TRANS1 AXIAL FIXATION SYSTEM?

The FDA product code for TRANS1 AXIAL FIXATION SYSTEM is KWQ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Trans1, Inc. 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.

K123997TRANS1LATERAL INTERBODY FUSION SYSTEMK032891TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT

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.

↑