FDA 510(k)

A-CIFT SoloFuse

K-Number: K172484 · 2018-05-08

Decision Date2018-05-08

Product CodeOVE

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

A-CIFT SoloFuse is the device name listed in this FDA 510(k) record. The listed applicant is Spinefrontier, Inc.. It received FDA 510(k) clearance on 2018-05-08 under 510(k) number K172484. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A-CIFT SoloFuse?

A-CIFT SoloFuse is a medical device that received FDA 510(k) clearance on 2018-05-08. The listed applicant is Spinefrontier, Inc.. The 510(k) number is K172484.

When did A-CIFT SoloFuse receive FDA 510(k) clearance?

A-CIFT SoloFuse received FDA 510(k) clearance on 2018-05-08, under 510(k) number K172484.

Who is the listed applicant for A-CIFT SoloFuse?

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

What is the FDA product code for A-CIFT SoloFuse?

The FDA product code for A-CIFT SoloFuse is OVE.

Other records listing Spinefrontier, 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.

K193106SpineFrontier Lumbar Interbody Fusion Device System

Related Devices (Code: OVE)

K261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution Spine K261279DeltaNEC Interbody SystemNexus Spine K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.K260660SABER-C SystemElevation Spine

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.