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FDA 510(k)

EXTENDED VERTIFLEX SPINAL SCREW SYSTEM

K-Number: K073245 · 2008-02-15

ApplicantVertiflex, Inc.
Decision Date2008-02-15
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXTENDED VERTIFLEX SPINAL SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Vertiflex, Inc.. It received FDA 510(k) clearance on 2008-02-15 under 510(k) number K073245. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTENDED VERTIFLEX SPINAL SCREW SYSTEM?

EXTENDED VERTIFLEX SPINAL SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2008-02-15. The listed applicant is Vertiflex, Inc.. The 510(k) number is K073245.

When did EXTENDED VERTIFLEX SPINAL SCREW SYSTEM receive FDA 510(k) clearance?

EXTENDED VERTIFLEX SPINAL SCREW SYSTEM received FDA 510(k) clearance on 2008-02-15, under 510(k) number K073245.

Who is the listed applicant for EXTENDED VERTIFLEX SPINAL SCREW SYSTEM?

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

What is the FDA product code for EXTENDED VERTIFLEX SPINAL SCREW SYSTEM?

The FDA product code for EXTENDED VERTIFLEX SPINAL SCREW SYSTEM is NKB.

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.

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Other records listing Vertiflex, 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.

K122509VERTIFLEX SPINOUS PROCESS FIXATION PLATEK122662VERTIFLEX DIRECT DECOMPRESSION SYSTEMK082270OCTANE VERTEBRAL BODY REPLACEMENT (VBR) SYSTEMK073143MODIFIED VERTIFLEX SPINAL SCREW SYSTEM

Related Devices (Code: NKB)

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.

K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim SirketiK262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix MedicalK262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.

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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