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FDA 510(k)

Calix-C Cervical Interbody Spacer

K-Number: K171075 · 2017-08-01

ApplicantX-Spine Systems, Inc.
Decision Date2017-08-01
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Calix-C Cervical Interbody Spacer is a medical device manufactured by X-Spine Systems, Inc.. It received FDA 510(k) clearance on 2017-08-01 under approval number K171075. 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 Calix-C Cervical Interbody Spacer?

Calix-C Cervical Interbody Spacer is a medical device that received FDA 510(k) clearance on 2017-08-01. It is manufactured by X-Spine Systems, Inc.. The 510(k) number is K171075.

When was Calix-C Cervical Interbody Spacer approved by the FDA?

Calix-C Cervical Interbody Spacer received FDA 510(k) clearance on 2017-08-01, under approval number K171075.

What company makes Calix-C Cervical Interbody Spacer?

Calix-C Cervical Interbody Spacer is manufactured by X-Spine Systems, Inc..

What is the FDA product code for Calix-C Cervical Interbody Spacer?

The FDA product code for Calix-C Cervical Interbody Spacer is ODP.

Related Clinical Trials

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Other Devices by X-Spine Systems, Inc.

K160959Xsert Lumbar Expandable Interbody System K162944Irix-C Cervical Integrated Fusion System K160428Certex Spinal Fixation System K160114Xspan Laminoplasty Fixation System K170119Calix Lumbar Spinal Implant System K171567IRIX-A Lumbar Integrated Fusion System

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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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