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FDA 510(k)

NOVEL VBR SPINAL SYSTEM

K-Number: K042201 · 2004-10-07

ApplicantAlphatec/Nexmed
Decision Date2004-10-07
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NOVEL VBR SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec/Nexmed. It received FDA 510(k) clearance on 2004-10-07 under 510(k) number K042201. 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 NOVEL VBR SPINAL SYSTEM?

NOVEL VBR SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2004-10-07. The listed applicant is Alphatec/Nexmed. The 510(k) number is K042201.

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

NOVEL VBR SPINAL SYSTEM received FDA 510(k) clearance on 2004-10-07, under 510(k) number K042201.

Who is the listed applicant for NOVEL VBR SPINAL SYSTEM?

The FDA 510(k) record lists Alphatec/Nexmed as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for NOVEL VBR SPINAL SYSTEM is MQP.

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Other records listing Alphatec/Nexmed 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.

K050830ZODIAC SPINAL FIXATION SYSTEMK051286ZODIAC SPINAL FIXATION SYSTEMK050553NOVEL VBR SPINAL SYSTEMK050390TAMARACK ANTERIOR THORACOLUNBARK050078ROC LUMBAR PLATING SYSTEMK042252NEXFLEX TOTAL HIP 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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