NuVasive® VersaTie® System

Q: What is the product code of K190418?

The FDA product code is OWI – Bone Fixation Cerclage, Sublaminar, a Class II (moderate risk) device regulated under 21 CFR 888.3010.

FDA 510(k) K190418 · Nu Vasive, Incorporated

Substantially Equivalent

510(k) numberK190418

Submission

Device name: NuVasive® VersaTie® System
Applicant: Nu Vasive, Incorporated
San Diego, CA, US
Received: February 21, 2019
Decision date: March 21, 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: OWI – Bone Fixation Cerclage, Sublaminar
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3010
Specialty: Orthopedic
Implant: Yes

Acts as a bone anchor for temporary stabilization, or used in conjunction with other medical implants of similar metals when wiring is needed, during development of a spinal fusion.

Other 510(k)s with product code OWI

510(k)	Device	Applicant	Decision
K261374	LigaPASS SystemOWI · Special	Medicrea International S.A.S	05/27/2026SE
K253615	Invictus Bands SystemOWI · Traditional	Alphatec Spine, Inc.	03/25/2026SE
K222097	OLYMPIC Deformity Band SystemOWI · Traditional	Astura Medical	05/04/2023SE
K230565	HILINE Fixation SystemOWI · Traditional	Globus Medical, Inc.	04/20/2023SE
K213659	LigaPASS 2.0 Ligament Augmentation SystemOWI · Traditional	Medicrea International SA	05/24/2022SE
K211057	LigaPASS® Spinal System, CD Horizon Spinal SystemOWI · Traditional	Medtronic, Inc.	05/27/2021SE
K201240	Mariner Cap SystemOWI · Traditional	SeaSpine Orthopedics Corporation	08/05/2020SE
K200281	The Gecko Spinal SystemOWI · Traditional	Ortho Development Corporation	03/31/2020SE
K200097	Response BandLoc Spinal FixationOWI · Traditional	OrthoPediatrics Corp.	03/16/2020SE
K191217	Jazz PFOWI · Traditional	Implanet, S.A.	08/02/2019SE

More from Implanet, S.A.

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® VersaTie® System cleared by the FDA?

NuVasive® VersaTie® System (K190418) received a 510(k) decision of Substantially Equivalent on March 21, 2019, 28 days after the submission was received.

What is the product code of K190418?

The FDA product code is OWI – Bone Fixation Cerclage, Sublaminar, a Class II (moderate risk) device regulated under 21 CFR 888.3010.