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Calix PC Spinal Implant System

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

Active United States

510(k) K112036

Overview

The Calix PC Spinal Implant System is a generally box or oval-shaped device with various holes throughout its geometry. Superior and inferior surfaces of the device have titanium-coated teeth to help prevent implant dislodgement or expulsion once placed in its desired location.

When used as an intervertebral body fusion device, the X-spine Calix PC System is intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease of the cervical spine. It received FDA 510(k) clearance under K112036 as substantially equivalent to a predicate device. The device is supplied by X-Spine Systems, Inc. and is authorized for use in the United States.

AI-generated from registry data, 22 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 NumberK112036 Date8 Nov 2011ClearedStatusActive

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 is the Calix PC Spinal Implant System used for?

    The Calix PC Spinal Implant System is used as an intervertebral body fusion device for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease of the cervical spine, helping to stabilize the spine and promote bone growth between vertebrae.

  • How is the Calix PC Spinal Implant System supplied and is it sterile?

    The device is supplied by X-Spine Systems, Inc. and is provided in a sterile condition for single-use implantation; the titanium-coated superior and inferior surfaces feature teeth designed to prevent dislodgement or expulsion after placement in the desired anatomical location.

  • What regulatory pathway was used for the Calix PC Spinal Implant System?

    The Calix PC Spinal Implant System received FDA 510(k) clearance under submission K112036, determined to be substantially equivalent to a predicate device, and was cleared via the traditional 510(k) pathway with product code ODP and review by the Orthopedic advisory committee.