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FDA 510(k)

Axis Chena Cervical PEEK Spacer System

K-Number: K181140 · 2018-11-16

ApplicantAxis Orthopaedics
Decision Date2018-11-16
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Axis Chena Cervical PEEK Spacer System is a medical device manufactured by Axis Orthopaedics. It received FDA 510(k) clearance on 2018-11-16 under approval number K181140. 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 Axis Chena Cervical PEEK Spacer System?

Axis Chena Cervical PEEK Spacer System is a medical device that received FDA 510(k) clearance on 2018-11-16. It is manufactured by Axis Orthopaedics. The 510(k) number is K181140.

When was Axis Chena Cervical PEEK Spacer System approved by the FDA?

Axis Chena Cervical PEEK Spacer System received FDA 510(k) clearance on 2018-11-16, under approval number K181140.

What company makes Axis Chena Cervical PEEK Spacer System?

Axis Chena Cervical PEEK Spacer System is manufactured by Axis Orthopaedics.

What is the FDA product code for Axis Chena Cervical PEEK Spacer System?

The FDA product code for Axis Chena Cervical PEEK Spacer System is ODP.

Related Clinical Trials

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Other Devices by Axis Orthopaedics

K180301AXIS 5.5 Lumbar Pedicle Screw System K173867Axis Anterior Cervical Plate System

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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