Cervical Spinal Truss System-Stand Alone (CSTS-SA)

Q: What is the product code of K190870?

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

FDA 510(k) K190870 · 4Web, Inc.

Substantially Equivalent

510(k) numberK190870

Submission

Device name: Cervical Spinal Truss System-Stand Alone (CSTS-SA)
Applicant: 4Web, Inc.
Frisco, TX, US
Received: April 3, 2019
Decision date: August 12, 2019
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

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

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 510(k)s with product code OVE

510(k)	Device	Applicant	Decision
K261882	Pisces-SC Standalone Cervical Interbody SystemOVE · Traditional	Osseus Fusions Systems, LLC	08/21/2026SE
K261451	ZSAlign Cervical Interbody SystemOVE · Traditional	ZSFab, Inc.	07/31/2026SE
K262094	E3D-C Interbody SystemOVE · Special	Evolution Spine	07/22/2026SE
K261279	DeltaNEC Interbody SystemOVE · Traditional	Nexus Spine	06/22/2026SE
K252982	CONDUIT ZERO-P VA Secured Spacer SystemOVE · Traditional	Avalign Technologies, Inc.	06/18/2026SE
K260036	NeckTune 3D SA Cervical CageOVE · Traditional	Medyssey Co, Ltd.	06/15/2026SE
K260660	SABER-C SystemOVE · Traditional	Elevation Spine	04/27/2026SE
K253213	SAGI Cervical Cage SystemOVE · Traditional	ZheJiang Decans Medical Devices Co., Ltd.	04/20/2026SE
K252774	Uni-C Cervical Cage SystemOVE · Traditional	ZheJiang Decans Medical Devices Co., Ltd.	04/15/2026SE
K260038	E3D-C Interbody SystemOVE · Special	Evolution Spine	02/04/2026SE

More from Evolution Spine

510(k)	Device	Decision
K253201	Lumbar Spine Truss System - Plating Solution (LSTS-PS)KWQ · Special	02/12/2026SE
K203065	Lumbar Spine Truss System Plating Solution (LSTS-PS)KWQ · Traditional	03/10/2021SE
K200002	Anterior Spine Truss System Stand Alone (ASTS-SA) Interbody Fusion DeviceOVD · Traditional	05/29/2020SE
K190926	Hammertoe Truss System (HTS)HTY · Traditional	07/23/2019SE
K172294	Osteotomy Truss System (OTS)HRS · Traditional	02/22/2018SE
K173159	Cervical Spinal Truss System (CSTS) Interbody Fusion DeviceODP · Traditional	01/08/2018SE
K172392	Lateral Spinal Truss System (LSTS) Interbody Fusion DeviceMAX · Traditional	11/07/2017SE
K171351	Posterior Spine Truss System (PSTS) Interbody Fusion DeviceMAX · Traditional	09/08/2017SE
K170851	Anterior Spine Truss System (STS) Interbody Fusion DeviceMAX · Traditional	08/07/2017SE
K153436	LATERAL Spine Truss SystemMAX · Traditional	06/06/2016SE

Questions and answers

When was Cervical Spinal Truss System-Stand Alone (CSTS-SA) cleared by the FDA?

Cervical Spinal Truss System-Stand Alone (CSTS-SA) (K190870) received a 510(k) decision of Substantially Equivalent on August 12, 2019, 131 days after the submission was received.

What is the product code of K190870?

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