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FDA 510(k)

A-CIFT SoloFuse

K-Number: K172484 · 2018-05-08

ApplicantSpinefrontier, Inc.
Decision Date2018-05-08
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

A-CIFT SoloFuse is a medical device manufactured by Spinefrontier, Inc.. It received FDA 510(k) clearance on 2018-05-08 under approval 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. It is manufactured by Spinefrontier, Inc.. The 510(k) number is K172484.

When was A-CIFT SoloFuse approved by the FDA?

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

What company makes A-CIFT SoloFuse?

A-CIFT SoloFuse is manufactured by Spinefrontier, Inc..

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

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

Other Devices by Spinefrontier, Inc.

K193106SpineFrontier Lumbar Interbody Fusion Device System

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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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