Home / 510(k) Clearances / K191565

510(k) K191565

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

K191565 is an FDA 510(k) premarket notification submitted by Titan Spine, Inc. for the device "Endoskeleton TCS Interbody Fusion Device". The FDA issued a decision of Substantially Equivalent on August 6, 2019. The device falls under product code OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical), a Class II device regulated under 21 CFR 888.3080. Titan Spine, Inc. has at least 10 other 510(k) clearances on record.

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

  • K261882 — Pisces-SC Standalone Cervical Interbody System (August 21, 2026)
  • K261451 — ZSAlign Cervical Interbody System (July 31, 2026)
  • K262094 — E3D™-C Interbody System (July 22, 2026)
  • K261279 — DeltaNEC Interbody System (June 22, 2026)
  • K252982 — CONDUIT™ ZERO-P™ VA Secured Spacer System (June 18, 2026)
  • K260036 — NeckTune™ 3D SA Cervical Cage (June 15, 2026)
  • K260660 — SABER-C System (April 27, 2026)
  • K253213 — SAGI Cervical Cage System (April 20, 2026)
  • K252774 — Uni-C Cervical Cage System (April 15, 2026)
  • K260038 — E3D™-C Interbody System (February 4, 2026)

FDA data resources