Rampart One Lumbar Interbody Fusion System

Q: What is the product code of K191091?

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

FDA 510(k) K191091 · Spineology, Inc.

Substantially Equivalent

510(k) numberK191091

Submission

Device name: Rampart One Lumbar Interbody Fusion System
Applicant: Spineology, Inc.
Saint Paul, MN, US
Received: April 24, 2019
Decision date: May 23, 2019
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

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

Intended to stabilize lumbar 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 OVD

510(k)	Device	Applicant	Decision
K262025	Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…OVD · Traditional	INNO Holdings Inc. DBA Innovasis	09/11/2026SE
K261408	SABER-XA SystemOVD · Traditional	Elevation Spine	08/03/2026SE
K261809	Interwedge® Standalone LateralOVD · Special	Foundation Surgical Group	07/31/2026SE
K261353	Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…OVD · Traditional	Kyocera Medical Technologies, Inc.	07/15/2026SE
K260810	Anteralign LS coverplateOVD · Traditional	Tyber Medical, LLC	06/10/2026SE
K254202	MectaLIF 3D Metal AnteriorOVD · Traditional	Medacta International S.A.	05/05/2026SE
K253401	SCRIPT Implant SystemOVD · Traditional	Globus Medical, Inc.	04/29/2026SE
K253559	Ventana A Anterior Lumbar Interbody SystemOVD · Traditional	Spinal Elements, Inc.	02/25/2026SE
K251829	DeGen Medical Patient Specific Implant (PSI) SystemOVD · Traditional	Degen Medical	12/08/2025SE
K251575	IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody SystemOVD · Traditional	Alphatec Spine	09/03/2025SE

More from Alphatec Spine

510(k)	Device	Decision
K251302	OptiMesh Multiplanar Expandable Interbody Fusion SystemOQB · Traditional	12/15/2025SE
K251943	Spineology Navigation InstrumentsOLO · Special	12/04/2025SE
K230927	OptiMesh Multiplanar Expandable Interbody Fusion SystemOQB · Traditional	11/01/2023SE
K231781	OptiMesh Multiplanar Expandable Interbody Fusion SystemOQB · Special	10/18/2023SE
K213876	Spineology Navigation InstrumentsOLO · Traditional	08/05/2022SE
K210155	Duo Expandable Interbody Fusion SystemMAX · Special	02/19/2021SE
K192047	Rampart One Lumbar Interbody Fusion SystemOVD · Special	08/23/2019SE
K190055	Duo Lumbar Interbody Fusion DeviceMAX · Special	03/07/2019SE
K182322	Duo Lumbar Interbody Fusion DeviceMAX · Traditional	10/24/2018SE
K182345	Spineology Navigation InstrumentsOLO · Special	09/21/2018SE

Questions and answers

When was Rampart One Lumbar Interbody Fusion System cleared by the FDA?

Rampart One Lumbar Interbody Fusion System (K191091) received a 510(k) decision of Substantially Equivalent on May 23, 2019, 29 days after the submission was received.

What is the product code of K191091?

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