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FDA 510(k)

CONCORDE VBR SPINAL SYSTEM

K-Number: K052746 · 2005-10-21

ApplicantDepuy Spine, Inc.
Decision Date2005-10-21
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CONCORDE VBR SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Spine, Inc.. It received FDA 510(k) clearance on 2005-10-21 under 510(k) number K052746. 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 CONCORDE VBR SPINAL SYSTEM?

CONCORDE VBR SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2005-10-21. The listed applicant is Depuy Spine, Inc.. The 510(k) number is K052746.

When did CONCORDE VBR SPINAL SYSTEM receive FDA 510(k) clearance?

CONCORDE VBR SPINAL SYSTEM received FDA 510(k) clearance on 2005-10-21, under 510(k) number K052746.

Who is the listed applicant for CONCORDE VBR SPINAL SYSTEM?

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

What is the FDA product code for CONCORDE VBR SPINAL SYSTEM?

The FDA product code for CONCORDE VBR SPINAL 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.

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Other records listing Depuy Spine, 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.

K201831CONFIDENCE Spinal Cement SystemK111136EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEMK121020VIPER SYSTEMK110353MOUNTAINEER OCT SPINAL SYSTEMK110216EXPEDIUM SYSTEM, VIPER SYSTEMK103133VEPER SYSTEM, EXPEDIUM SYSTEM

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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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