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510(k) K192054

Endoskeleton TAS Plate by Titan Spine, Inc. — Product Code OVD

K192054 is an FDA 510(k) premarket notification submitted by Titan Spine, Inc. for the device "Endoskeleton TAS Plate". The FDA issued a decision of Substantially Equivalent on August 29, 2019. The device falls under product code OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar), 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 29, 2019
Date Received
July 31, 2019
Clearance Type
Special
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.

  • K191581 — Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody (January 8, 2020)
  • 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

  • K262025 — Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis (September 11, 2026)
  • K261408 — SABER-XA System (August 3, 2026)
  • K261809 — Interwedge® Standalone Lateral (July 31, 2026)
  • K261353 — Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lum (July 15, 2026)
  • K260810 — Anteralign LS coverplate (June 10, 2026)
  • K254202 — MectaLIF 3D Metal Anterior (May 5, 2026)
  • K253401 — SCRIPT™ Implant System (April 29, 2026)
  • 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)

FDA data resources