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FDA 510(k)

ACIF

K-Number: K173148 · 2017-12-01

ApplicantColigne AG
Decision Date2017-12-01
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACIF is a medical device manufactured by Coligne AG. It received FDA 510(k) clearance on 2017-12-01 under approval number K173148. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACIF?

ACIF is a medical device that received FDA 510(k) clearance on 2017-12-01. It is manufactured by Coligne AG. The 510(k) number is K173148.

When was ACIF approved by the FDA?

ACIF received FDA 510(k) clearance on 2017-12-01, under approval number K173148.

What company makes ACIF?

ACIF is manufactured by Coligne AG.

What is the FDA product code for ACIF?

The FDA product code for ACIF is ODP.

Other Devices by Coligne AG

K181963ostaPek Interbody Fusion Cages K173893Trabis K210306GII Spinal Fixation System

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K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

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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