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Calix-C Cervical Interbody Spacer

by X-Spine Systems, Inc. 510(k)

Active United States

510(k) K171075

Overview

The Calix-C Cervical Interbody Spacer is a spinal implant classified as an Orthopedic Device Product (ODP) under FDA nomenclature. It is designed as a cervical interbody fusion device intended for placement between vertebral bodies from C2 to T1 in skeletally mature patients undergoing spinal fusion procedures.

The device is supplied as a reusable system comprising precision instruments and implants, intended for use in open, anterior surgical approaches. It is not described as sterile or single-use in the provided data, and no MRI safety information is specified. The device holds an FDA 510(k) clearance under the Traditional pathway, classified as Substantially Equivalent to a predicate device, with a clearance date of August 1, 2017.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK171075 Date1 Aug 2017ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
ODP
Device Class
Class II
Regulation
21 CFR Part 888.3080
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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Questions

  • What surgical approaches is the Calix-C Cervical Interbody Spacer designed for, and how is it supplied?

    The Calix-C Cervical Interbody Spacer is designed for use in open, anterior surgical approaches to the cervical spine. It is supplied as a reusable system, which includes both precision instruments and the implants themselves, rather than as a single-use or sterile package.

  • What is the intended spinal region for placement of the Calix-C Cervical Interbody Spacer, and what patient population is it intended for?

    The Calix-C Cervical Interbody Spacer is intended for placement between vertebral bodies from C2 to T1 in skeletally mature patients undergoing spinal fusion procedures. This means it is specifically designed for the cervical spine region, excluding the lower cervical levels (below T1) and pediatric or adolescent patients.

  • How is the regulatory status of the Calix-C Cervical Interbody Spacer determined, and what type of clearance does it hold?

    The Calix-C Cervical Interbody Spacer holds an FDA 510(k) clearance under the Traditional pathway, classified as Substantially Equivalent to a predicate device. This means the FDA determined it is as safe and effective as a previously approved device, rather than requiring a de novo or PMA pathway. The clearance was granted on August 1, 2017.

  • Is the Calix-C Cervical Interbody Spacer intended for MRI compatibility, and what are its key specifications regarding reuse?

    The provided data does not specify MRI safety information for the Calix-C Cervical Interbody Spacer, so its compatibility with MRI procedures cannot be confirmed. The device is explicitly described as a reusable system, meaning it is not intended for single-use and is designed to be cleaned and reused in surgical settings.