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510(k) K211704

CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer System, FORZA PEEK Spacer System, FORZA PTC Spacer System, FORZA Ti Spacer System, FORZA XP Expandable Spacer System, Lonestar Cervical Standalone System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, PILLAR SA PTC Spacer System, SKYHAWK Lateral Interbody Fusion System by Orthofix, Inc. — Product Code ODP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2021
Date Received
June 3, 2021
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 Orthofix, Inc.

  • K250112 — FitboneTM Trochanteric (April 10, 2025)
  • K242270 — OrthoNext Platform System (December 19, 2024)
  • K242861 — TrueLok Elevate (December 3, 2024)
  • K233867 — Fitbone Trochanteric (June 18, 2024)
  • K240749 — PILLAR SA Ti Spacer System (82-XXX) (May 28, 2024)
  • K232648 — RODEO Telescopic Nail (May 3, 2024)
  • K232169 — FITBONE® Transport and Lengthening System (March 22, 2024)
  • K213572 — JuniOrtho Plating System™ (January 18, 2022)
  • K212044 — TrueLok Evo (November 5, 2021)
  • K211710 — Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebir (July 30, 2021)

Other clearances for product code ODP

  • K254105 — Hive™ Standalone Cervical System and Hive™ C Interbody System (February 13, 2026)
  • K252205 — Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Inte (January 16, 2026)
  • K254061 — Curiteva Porous PEEK Cervical Interbody Fusion System (January 15, 2026)
  • 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)