Home / 510(k) Clearances / K183557

510(k) K183557

Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device by Titan Spine, Inc. — Product Code ODP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2019
Date Received
December 20, 2018
Clearance Type
Special
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 Titan Spine, Inc.

  • K191581 — Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody (January 8, 2020)
  • K192054 — Endoskeleton TAS Plate (August 29, 2019)
  • K192018 — Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic (August 16, 2019)
  • K191565 — Endoskeleton TCS Interbody Fusion Device (August 6, 2019)
  • K173535 — Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Inter (February 13, 2018)
  • K170399 — Endoskeleton TO Interbody Fusion Device (IBD) (July 6, 2017)
  • K163269 — Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic (April 13, 2017)
  • K153122 — Endoskeleton(r) TCS System (December 14, 2015)
  • K151596 — Endoskeleton TCS Interbody Fusion Device (October 9, 2015)
  • K142940 — Endoskeleton TCS System (January 28, 2015)

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)