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510(k) K171075

Calix-C Cervical Interbody Spacer by X-Spine Systems, Inc. — Product Code ODP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2017
Date Received
April 11, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Cervical
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other clearances by X-Spine Systems, Inc.

  • K173832 — InTice™-C Porous Ti Cervical Interbody System (May 17, 2018)
  • K180153 — X-spine Cortical Bone Screw System (March 15, 2018)
  • K170119 — Calix Lumbar Spinal Implant System (September 29, 2017)
  • K171567 — IRIX-A Lumbar Integrated Fusion System (August 28, 2017)
  • K170224 — Spider Cervical Plating System (July 6, 2017)
  • K170530 — Butrex Lumbar Buttress Plating System (March 22, 2017)
  • K160959 — Xsert Lumbar Expandable Interbody System (November 17, 2016)
  • K162944 — Irix-C Cervical Integrated Fusion System (November 7, 2016)
  • K160428 — Certex Spinal Fixation System (May 5, 2016)
  • K160114 — Xspan Laminoplasty Fixation System (March 15, 2016)

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  • K252219 — Cervical Interbody and VBR Fusion System (January 14, 2026)
  • K252711 — Advantage-C™ Ti3D Cervical Interbody Fusion Device (January 8, 2026)
  • K252894 — aprevo® cervical interbody system (January 6, 2026)
  • K252781 — MSFX MIKRON PEEK CAGES (December 19, 2025)
  • K250764 — SpineLinc Anterior Cervical Implant System (December 5, 2025)
  • K250769 — Dakota LP System (November 24, 2025)
  • K252686 — EffortMed PEEK Cages & Corpectomy Cages (November 21, 2025)