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FDA 510(k)

VERTIFLEX OCTANE PEEK VERTEBRAL BODY REPLACEMENT (PEEK VBR)

K-Number: K070218 · 2007-04-06

ApplicantVertiflex (Tm), Incorporated
Decision Date2007-04-06
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VERTIFLEX OCTANE PEEK VERTEBRAL BODY REPLACEMENT (PEEK VBR) is the device name listed in this FDA 510(k) record. The listed applicant is Vertiflex (Tm), Incorporated. It received FDA 510(k) clearance on 2007-04-06 under 510(k) number K070218. 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 VERTIFLEX OCTANE PEEK VERTEBRAL BODY REPLACEMENT (PEEK VBR)?

VERTIFLEX OCTANE PEEK VERTEBRAL BODY REPLACEMENT (PEEK VBR) is a medical device that received FDA 510(k) clearance on 2007-04-06. The listed applicant is Vertiflex (Tm), Incorporated. The 510(k) number is K070218.

When did VERTIFLEX OCTANE PEEK VERTEBRAL BODY REPLACEMENT (PEEK VBR) receive FDA 510(k) clearance?

VERTIFLEX OCTANE PEEK VERTEBRAL BODY REPLACEMENT (PEEK VBR) received FDA 510(k) clearance on 2007-04-06, under 510(k) number K070218.

Who is the listed applicant for VERTIFLEX OCTANE PEEK VERTEBRAL BODY REPLACEMENT (PEEK VBR)?

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

What is the FDA product code for VERTIFLEX OCTANE PEEK VERTEBRAL BODY REPLACEMENT (PEEK VBR)?

The FDA product code for VERTIFLEX OCTANE PEEK VERTEBRAL BODY REPLACEMENT (PEEK VBR) 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 Vertiflex (Tm), Incorporated 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.

K062670VERTIFLEX SPINAL SCREW SYSTEM

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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