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FDA 510(k)

MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT SYSTEM

K-Number: K061576 · 2006-07-03

ApplicantQuantum Orthopedics, Inc.
Decision Date2006-07-03
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Quantum Orthopedics, Inc.. It received FDA 510(k) clearance on 2006-07-03 under 510(k) number K061576. 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 MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT SYSTEM?

MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2006-07-03. The listed applicant is Quantum Orthopedics, Inc.. The 510(k) number is K061576.

When did MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT SYSTEM received FDA 510(k) clearance on 2006-07-03, under 510(k) number K061576.

Who is the listed applicant for MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT SYSTEM?

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

What is the FDA product code for MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT SYSTEM?

The FDA product code for MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT 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 Quantum Orthopedics, 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.

K062004MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENTK052641MODIFICATION TO: QUANTUM VERTEBRAL BODY REPLACEMENTK060491QUANTUM ANTERIOR CERVICAL PLATE SYSTEMK050449QUANTUM VERTEBRAL BODY REPLACEMENT

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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