Ventris Intervertebral Body Fusion Device

Q: What is the product code of K243386?

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) K243386 · Acuity Surgical Devices, LLC

Substantially Equivalent

510(k) numberK243386

Submission

Device name: Ventris Intervertebral Body Fusion Device
Applicant: Acuity Surgical Devices, LLC
Irving, TX, US
Received: October 31, 2024
Decision date: April 22, 2025
Decision: Substantially Equivalent (SESE)
Type: Traditional 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
K251735	Stabilis SA Cervical Stand-Alone System (Various PNs)OVE · Traditional	07/30/2025SE
K251335	Tera Lumbar Interbody Fusion System (Various PNs)MAX · Traditional	06/02/2025SE
K241413	sagAlign Lumbar Cage System (Various PNs)MAX · Traditional	07/17/2024SE
K230639	Align Cervical Interbody Fusion SystemODP · Traditional	12/01/2023SE
K222561	AlignOVD · Special	09/23/2022SE
K221535	Align Lumbar Interbody Fusion SystemMAX · Traditional	07/22/2022SE
K201671	A-Link ZOVD · Traditional	05/04/2021SE

Questions and answers

When was Ventris Intervertebral Body Fusion Device cleared by the FDA?

Ventris Intervertebral Body Fusion Device (K243386) received a 510(k) decision of Substantially Equivalent on April 22, 2025, 173 days after the submission was received.

What is the product code of K243386?

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.