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FDA 510(k)

THEKEN REVEAL VBR SYSTEM

K-Number: K050058 · 2005-05-17

ApplicantTheken Surgical,Llc
Decision Date2005-05-17
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

THEKEN REVEAL VBR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Theken Surgical,Llc. It received FDA 510(k) clearance on 2005-05-17 under 510(k) number K050058. 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 THEKEN REVEAL VBR SYSTEM?

THEKEN REVEAL VBR SYSTEM is a medical device that received FDA 510(k) clearance on 2005-05-17. The listed applicant is Theken Surgical,Llc. The 510(k) number is K050058.

When did THEKEN REVEAL VBR SYSTEM receive FDA 510(k) clearance?

THEKEN REVEAL VBR SYSTEM received FDA 510(k) clearance on 2005-05-17, under 510(k) number K050058.

Who is the listed applicant for THEKEN REVEAL VBR SYSTEM?

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

What is the FDA product code for THEKEN REVEAL VBR SYSTEM?

The FDA product code for THEKEN REVEAL VBR SYSTEM 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

Other records listing Theken Surgical,Llc 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.

K032064THEKEN CPOD/LPOD VERTEBRAL BODY REPLACEMENT SYSTEMK012462THEKEN LARGE CEMENT RESTRICTORK012278THEKEN SMALL CEMENT RESTRICTORK010466TETHER ACFSK983622BODYFORM THORACO-LUMBAR FIXATION SYSTEM

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

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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