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510(k) K191565

Endoskeleton TCS Interbody Fusion Device by Titan Spine, Inc. — Product Code OVE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2019
Date Received
June 13, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Integrated Fixation, 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 with or without supplemental fixation.

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)
  • K183557 — Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Dev (February 11, 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 OVE

  • K260038 — E3D™-C Interbody System (February 4, 2026)
  • K253876 — HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) (December 22, 2025)
  • K253200 — Cervical Spine Truss System - Stand Alone (CSTS-SA) (December 11, 2025)
  • K250076 — Endeavor™ Stand-Alone Cervical IBF System (September 25, 2025)
  • K250540 — SABER-C System (August 8, 2025)
  • K251735 — Stabilis SA Cervical Stand-Alone System (Various PNs) (July 30, 2025)
  • K251431 — FIX-C PEEK ACIF SA System (June 27, 2025)
  • K251117 — Cervical Spine Truss System (CSTS) (April 25, 2025)
  • K242928 — Tesera-k SC System (April 10, 2025)
  • K243188 — CYLOX® ST (February 11, 2025)