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FDA 510(k)

OCTANE VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM

K-Number: K082270 · 2008-09-16

ApplicantVertiflex, Inc.
Decision Date2008-09-16
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OCTANE VERTEBRAL BODY REPLACEMENT (VBR) 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 2008-09-16 under 510(k) number K082270. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OCTANE VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM?

OCTANE VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM is a medical device that received FDA 510(k) clearance on 2008-09-16. The listed applicant is Vertiflex, Inc.. The 510(k) number is K082270.

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

OCTANE VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM received FDA 510(k) clearance on 2008-09-16, under 510(k) number K082270.

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

The FDA product code for OCTANE VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM is MAX.

Related Clinical Trials

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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 SYSTEMK073143MODIFIED VERTIFLEX SPINAL SCREW SYSTEMK073245EXTENDED VERTIFLEX SPINAL SCREW SYSTEM

Related Devices (Code: MAX)

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.

K261049SCALA® TLSpineart SAK261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.

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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