Cervical Stand-Alone System

Q: What is the product code of K212853?

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) K212853 · Eminent Spine, LLC

Substantially Equivalent

510(k) numberK212853

Submission

Device name: Cervical Stand-Alone System
Applicant: Eminent Spine, LLC
Plano, TX, US
Received: September 7, 2021
Decision date: November 5, 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
K250894	Eminent Spine Posterior SI SystemOUR · Traditional	10/07/2025SE
K241663	Eminent Spine 3D Titanium Pedicle Screw SystemNKB · Traditional	04/28/2025SE
K242069	Eminent Spine Scoliosis Deformity Pedicle Screw SystemNKB · Special	09/03/2024SE
K240505	Eminent Spine SI Screw SystemOUR · Traditional	06/04/2024SE
K230219	Eminent Spine 3D Lumbar Interbody Fusion SystemsMAX · Traditional	05/16/2023SE
K212701	Eminent Spine 3D Cervical Interbody Fusion SystemODP · Traditional	02/06/2023SE
K221936	Standalone ALIF Interbody Fusion SystemOVD · Traditional	10/17/2022SE
K201979	Cervical Plate SystemKWQ · Traditional	08/25/2020SE
K143365	Eminent Foot Plate SystemHRS · Traditional	03/30/2015SE
K133194	Diamond Rattlesnake SystemKWQ · Traditional	06/26/2014SE

Questions and answers

When was Cervical Stand-Alone System cleared by the FDA?

Cervical Stand-Alone System (K212853) received a 510(k) decision of Substantially Equivalent on November 5, 2021, 59 days after the submission was received.

What is the product code of K212853?

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.