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FDA 510(k)

ACCUFUSE Cervical System

K-Number: K181471 · 2018-08-29

ApplicantAbsolute Advantage Medical, LLC
Decision Date2018-08-29
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACCUFUSE Cervical System is a medical device manufactured by Absolute Advantage Medical, LLC. It received FDA 510(k) clearance on 2018-08-29 under approval number K181471. 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 ACCUFUSE Cervical System?

ACCUFUSE Cervical System is a medical device that received FDA 510(k) clearance on 2018-08-29. It is manufactured by Absolute Advantage Medical, LLC. The 510(k) number is K181471.

When was ACCUFUSE Cervical System approved by the FDA?

ACCUFUSE Cervical System received FDA 510(k) clearance on 2018-08-29, under approval number K181471.

What company makes ACCUFUSE Cervical System?

ACCUFUSE Cervical System is manufactured by Absolute Advantage Medical, LLC.

What is the FDA product code for ACCUFUSE Cervical System?

The FDA product code for ACCUFUSE Cervical System is ODP.

Related Clinical Trials

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Related Devices (Code: ODP)

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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