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FDA 510(k)

CREASPINE SUPSTANCE SMALL VERTEBRAL BODY REPLACEMENT SYSTEM

K-Number: K080860 · 2008-05-29

ApplicantCreaspine
Decision Date2008-05-29
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CREASPINE SUPSTANCE SMALL VERTEBRAL BODY REPLACEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Creaspine. It received FDA 510(k) clearance on 2008-05-29 under 510(k) number K080860. 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 CREASPINE SUPSTANCE SMALL VERTEBRAL BODY REPLACEMENT SYSTEM?

CREASPINE SUPSTANCE SMALL VERTEBRAL BODY REPLACEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2008-05-29. The listed applicant is Creaspine. The 510(k) number is K080860.

When did CREASPINE SUPSTANCE SMALL VERTEBRAL BODY REPLACEMENT SYSTEM receive FDA 510(k) clearance?

CREASPINE SUPSTANCE SMALL VERTEBRAL BODY REPLACEMENT SYSTEM received FDA 510(k) clearance on 2008-05-29, under 510(k) number K080860.

Who is the listed applicant for CREASPINE SUPSTANCE SMALL VERTEBRAL BODY REPLACEMENT SYSTEM?

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

What is the FDA product code for CREASPINE SUPSTANCE SMALL VERTEBRAL BODY REPLACEMENT SYSTEM?

The FDA product code for CREASPINE SUPSTANCE SMALL 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 Creaspine 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.

K081564CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM LINE EXTENSION

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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