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FDA 510(k)

GIZA(R) VERTEBRAL BODY REPLACEMENT

K-Number: K112429 · 2012-01-26

ApplicantEden Spine, LLC
Decision Date2012-01-26
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GIZA(R) VERTEBRAL BODY REPLACEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Eden Spine, LLC. It received FDA 510(k) clearance on 2012-01-26 under 510(k) number K112429. 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 GIZA(R) VERTEBRAL BODY REPLACEMENT?

GIZA(R) VERTEBRAL BODY REPLACEMENT is a medical device that received FDA 510(k) clearance on 2012-01-26. The listed applicant is Eden Spine, LLC. The 510(k) number is K112429.

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

GIZA(R) VERTEBRAL BODY REPLACEMENT received FDA 510(k) clearance on 2012-01-26, under 510(k) number K112429.

Who is the listed applicant for GIZA(R) VERTEBRAL BODY REPLACEMENT?

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

What is the FDA product code for GIZA(R) VERTEBRAL BODY REPLACEMENT?

The FDA product code for GIZA(R) 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.

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 Eden Spine, 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.

K160982Sphynx™

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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