Vault-C Intervertebral Body Fusion Device

Q: What is the product code of K132029?

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) K132029 · Spinal USA

Substantially Equivalent

510(k) numberK132029

Submission

Device name: Vault-C Intervertebral Body Fusion Device
Applicant: Spinal USA
Colorado Springs, CO, US
Received: July 1, 2013
Decision date: November 25, 2013
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

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K130863	Facet Screw SystemMRW · Traditional	08/09/2013SE
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K130279	Reform Pedicle Screw SystemMNI · Traditional	06/20/2013SE
K130445	Vault Alif SystemOVD · Special	04/25/2013SE
K122931	S-Lok PSS SystemMNI · Traditional	11/20/2012SE
K121172	Reform Pedicle Screw SystemMNI · Special	08/08/2012SE
K112748	Slimplicity Solo Anterior Cervical Plate SystemKWQ · Traditional	07/11/2012SE
K112025	Sure Lok Mini Posterior Cervical/Upper Thoracic SystemKWP · Traditional	09/15/2011SE
K103369	Vault Alif SystemOVD · Traditional	04/04/2011SE
K092659	Spinal USA RCS Anterior Lumbar Butress Plate System, Model 22-1001-25KWQ · Traditional	11/17/2009SE

Questions and answers

When was Vault-C Intervertebral Body Fusion Device cleared by the FDA?

Vault-C Intervertebral Body Fusion Device (K132029) received a 510(k) decision of Substantially Equivalent on November 25, 2013, 147 days after the submission was received.

What is the product code of K132029?

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.