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FDA 510(k)

PHENIX VERTEBRAL BODY REPLACEMENT

K-Number: K072029 · 2007-10-15

ApplicantNew Business Development, LLC
Decision Date2007-10-15
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PHENIX VERTEBRAL BODY REPLACEMENT is the device name listed in this FDA 510(k) record. The listed applicant is New Business Development, LLC. It received FDA 510(k) clearance on 2007-10-15 under 510(k) number K072029. 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 PHENIX VERTEBRAL BODY REPLACEMENT?

PHENIX VERTEBRAL BODY REPLACEMENT is a medical device that received FDA 510(k) clearance on 2007-10-15. The listed applicant is New Business Development, LLC. The 510(k) number is K072029.

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

PHENIX VERTEBRAL BODY REPLACEMENT received FDA 510(k) clearance on 2007-10-15, under 510(k) number K072029.

Who is the listed applicant for PHENIX VERTEBRAL BODY REPLACEMENT?

The FDA 510(k) record lists New Business Development, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHENIX VERTEBRAL BODY REPLACEMENT?

The FDA product code for PHENIX VERTEBRAL BODY REPLACEMENT 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 New Business Development, 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.

K050377NBD HEAD SCREWK032196NBD DISPOSABLE RF CANNULAEK021788NBD CEMENT RESTRICTOR DEVICE

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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