NuVasive 3DP Interfixated ALIF System

Q: What is the product code of K193593?

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) K193593 · Nu Vasive, Incorporated

Substantially Equivalent

510(k) numberK193593

Submission

Device name: NuVasive 3DP Interfixated ALIF System
Applicant: Nu Vasive, Incorporated
San Diego, CA, US
Received: December 23, 2019
Decision date: March 25, 2020
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
K231735	NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…ODP · Special	07/11/2023SE
K230894	NuVasive Modulus ALIF SystemOVD · Traditional	06/16/2023SE
K230989	Rod Registration FrameOLO · Special	05/05/2023SE
K223181	NuVasive Reline SystemNKB · Traditional	01/11/2023SE
K221751	NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceOVD · Traditional	10/21/2022SE
K221388	NuVasive Reline Cervical SystemNKG · Traditional	09/09/2022SE
K220478	NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemMAX · Traditional	06/21/2022SE
K213654	NuVasive Reline Cervical SystemNKG · Traditional	02/23/2022SE
K203714	NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…MAX · Traditional	12/23/2021SE
K212446	NuVasive Anterior Cervical Plate SystemsKWQ · Traditional	11/03/2021SE

Questions and answers

When was NuVasive 3DP Interfixated ALIF System cleared by the FDA?

NuVasive 3DP Interfixated ALIF System (K193593) received a 510(k) decision of Substantially Equivalent on March 25, 2020, 93 days after the submission was received.

What is the product code of K193593?

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.