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FDA 510(k)

FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5

K-Number: K042713 · 2004-12-29

ApplicantSpine Next America Corporation
Decision Date2004-12-29
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5 is the device name listed in this FDA 510(k) record. The listed applicant is Spine Next America Corporation. It received FDA 510(k) clearance on 2004-12-29 under 510(k) number K042713. 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 FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5?

FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5 is a medical device that received FDA 510(k) clearance on 2004-12-29. The listed applicant is Spine Next America Corporation. The 510(k) number is K042713.

When did FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5 receive FDA 510(k) clearance?

FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5 received FDA 510(k) clearance on 2004-12-29, under 510(k) number K042713.

Who is the listed applicant for FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5?

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

What is the FDA product code for FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5?

The FDA product code for FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5 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 Spine Next America Corporation 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.

K042714FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 1, 2, 3 AND 4

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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