Home / 510(k) Clearances / K191581

510(k) K191581

Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device by Titan Spine, Inc. — Product Code OVD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2020
Date Received
June 14, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize lumbar 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.

  • 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)
  • 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 OVD

  • K253559 — Ventana™ A Anterior Lumbar Interbody System (February 25, 2026)
  • K251829 — DeGen Medical Patient Specific Implant (PSI) System (December 8, 2025)
  • K251575 — IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interb (September 3, 2025)
  • K250072 — CONDUIT™ SYNFIX™ Evolution Secured Spacer System (July 10, 2025)
  • K251644 — ProAM ALIF System (June 24, 2025)
  • K250845 — Curiteva Porous PEEK Standalone ALIF System (June 18, 2025)
  • K251459 — OneLIF™ Interbody Fusion System (June 12, 2025)
  • K243934 — Stable-L Lumbar Interbody System (April 30, 2025)
  • K243386 — Ventris Intervertebral Body Fusion Device (April 22, 2025)
  • K250603 — AxTiHA® Stand-Alone ALIF System (March 24, 2025)