Endoskeleton TAS Plate

Q: What is the product code of K192054?

The FDA product code is OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.

FDA 510(k) K192054 · Titan Spine, Inc.

Substantially Equivalent

510(k) numberK192054

Submission

Device name: Endoskeleton TAS Plate
Applicant: Titan Spine, Inc.
Mequon, WI, US
Received: July 31, 2019
Decision date: August 29, 2019
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3080
Specialty: Orthopedic
Implant: Yes

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 510(k)s with product code OVD

510(k)	Device	Applicant	Decision
K262025	Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…OVD · Traditional	INNO Holdings Inc. DBA Innovasis	09/11/2026SE
K261408	SABER-XA SystemOVD · Traditional	Elevation Spine	08/03/2026SE
K261809	Interwedge® Standalone LateralOVD · Special	Foundation Surgical Group	07/31/2026SE
K261353	Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…OVD · Traditional	Kyocera Medical Technologies, Inc.	07/15/2026SE
K260810	Anteralign LS coverplateOVD · Traditional	Tyber Medical, LLC	06/10/2026SE
K254202	MectaLIF 3D Metal AnteriorOVD · Traditional	Medacta International S.A.	05/05/2026SE
K253401	SCRIPT Implant SystemOVD · Traditional	Globus Medical, Inc.	04/29/2026SE
K253559	Ventana A Anterior Lumbar Interbody SystemOVD · Traditional	Spinal Elements, Inc.	02/25/2026SE
K251829	DeGen Medical Patient Specific Implant (PSI) SystemOVD · Traditional	Degen Medical	12/08/2025SE
K251575	IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody SystemOVD · Traditional	Alphatec Spine	09/03/2025SE

More from Alphatec Spine

510(k)	Device	Decision
K191581	Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…OVD · Traditional	01/08/2020SE
K192018	Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…ODP · Special	08/16/2019SE
K191565	Endoskeleton TCS Interbody Fusion DeviceOVE · Special	08/06/2019SE
K183557	Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…ODP · Special	02/11/2019SE
K173535	Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…ODP · Special	02/13/2018SE
K170399	Endoskeleton TO Interbody Fusion Device (IBD)MAX · Traditional	07/06/2017SE
K163269	Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic…OVD · Traditional	04/13/2017SE
K153122	Endoskeleton(r) TCS SystemOVE · Traditional	12/14/2015SE
K151596	Endoskeleton TCS Interbody Fusion DeviceOVE · Traditional	10/09/2015SE
K142940	Endoskeleton TCS SystemOVE · Traditional	01/28/2015SE

Questions and answers

When was Endoskeleton TAS Plate cleared by the FDA?

Endoskeleton TAS Plate (K192054) received a 510(k) decision of Substantially Equivalent on August 29, 2019, 29 days after the submission was received.

What is the product code of K192054?

The FDA product code is OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.