Velofix SA Cervical Cage

Q: What is the product code of K210573?

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) K210573 · U&I Corporation

Substantially Equivalent

510(k) numberK210573

Submission

Device name: Velofix SA Cervical Cage
Applicant: U&I Corporation
Uijeongbu-Si, KR
Received: February 26, 2021
Decision date: November 19, 2021
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
K220147	Aspiron S ACP SystemKWQ · Special	02/16/2022SE
K183243	Velofix TLIF CageMAX · Special	07/10/2019SE
K190067	Velofix Interbody Fusion SystemODP · Special	02/04/2019SE
K190053	SECULOK ACP SystemKWQ · Special	02/01/2019SE
K181824	CBT Screw Fixation SystemNKB · Traditional	12/13/2018SE
K183383	ANAX OCT Spinal SystemNKG · Special	12/12/2018SE
K181829	Velofix TLIF CageMAX · Special	11/14/2018SE
K182055	SECULOK ACP SystemKWQ · Traditional	09/10/2018SE
K180759	SECULOK Suture AnchorMBI · Traditional	08/09/2018SE
K173198	Facet Screw Fixation SystemMRW · Traditional	01/03/2018SE

Questions and answers

When was Velofix SA Cervical Cage cleared by the FDA?

Velofix SA Cervical Cage (K210573) received a 510(k) decision of Substantially Equivalent on November 19, 2021, 266 days after the submission was received.

What is the product code of K210573?

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.