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FDA 510(k)

EXPANSE VERTEBRAL BODY REPLACEMENT DEVICE

K-Number: K050997 · 2005-10-07

ApplicantFlexuspine, Inc.
Decision Date2005-10-07
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXPANSE VERTEBRAL BODY REPLACEMENT DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Flexuspine, Inc.. It received FDA 510(k) clearance on 2005-10-07 under 510(k) number K050997. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXPANSE VERTEBRAL BODY REPLACEMENT DEVICE?

EXPANSE VERTEBRAL BODY REPLACEMENT DEVICE is a medical device that received FDA 510(k) clearance on 2005-10-07. The listed applicant is Flexuspine, Inc.. The 510(k) number is K050997.

When did EXPANSE VERTEBRAL BODY REPLACEMENT DEVICE receive FDA 510(k) clearance?

EXPANSE VERTEBRAL BODY REPLACEMENT DEVICE received FDA 510(k) clearance on 2005-10-07, under 510(k) number K050997.

Who is the listed applicant for EXPANSE VERTEBRAL BODY REPLACEMENT DEVICE?

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

What is the FDA product code for EXPANSE VERTEBRAL BODY REPLACEMENT DEVICE?

The FDA product code for EXPANSE VERTEBRAL BODY REPLACEMENT DEVICE is MQP.

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

Related Devices (Code: MQP)

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.

K261810Vertiwedge® Intraosseous SystemFoundation Surgical GroupK261031POSEIDON STSignus Medinzintechnik GmbHK253158VyBrate™ VBR SystemVy Spine, LLCK241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AGK233359DOMINION Expandable Corpectomy SystemAstura Medical

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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