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FDA 510(k)

VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM

K-Number: K061155 · 2006-09-22

ApplicantZimmer Trabecular
Decision Date2006-09-22
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Trabecular. It received FDA 510(k) clearance on 2006-09-22 under 510(k) number K061155. 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 VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM?

VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2006-09-22. The listed applicant is Zimmer Trabecular. The 510(k) number is K061155.

When did VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM receive FDA 510(k) clearance?

VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM received FDA 510(k) clearance on 2006-09-22, under 510(k) number K061155.

Who is the listed applicant for VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM?

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

What is the FDA product code for VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM?

The FDA product code for VISTA P 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 Zimmer Trabecular 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.

K061067TRABECULAR METAL ACETABULAR AUGMENTSK053340TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTSK052950THE ZIMMER TMT TRABECULAR METAL VERTEBRAL BODY REPLACEMENT SYSTEMK051756MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZK050766EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEMK050937TRABECULAR METAL ACETABULAR REVISION SHELLS

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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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