UniSpace® Stand-Alone C Cage

Q: What is the product code of K234119?

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) K234119 · Innosys Co., Ltd.

Substantially Equivalent

510(k) numberK234119

Submission

Device name: UniSpace® Stand-Alone C Cage
Applicant: Innosys Co., Ltd.
Uijeongbu-Si, KR
Received: December 28, 2023
Decision date: April 19, 2024
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
K241082	INNOVERSE Navigation InstrumentsOLO · Traditional	06/14/2024SE
K233960	INNOVERSE Spinal SystemNKB · Traditional	02/06/2024SE
K231737	ANAX 5.5 Spinal SystemNKB · Special	10/26/2023SE
K221084	Dyna Locking Trochanteric NailHSB · Special	03/03/2023SE

Questions and answers

When was UniSpace® Stand-Alone C Cage cleared by the FDA?

UniSpace® Stand-Alone C Cage (K234119) received a 510(k) decision of Substantially Equivalent on April 19, 2024, 113 days after the submission was received.

What is the product code of K234119?

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.