MAGNIFY and MAGNIFY-S Spacers

Q: What is the product code of K142498?

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) K142498 · Globus Medical, Inc.

Substantially Equivalent

510(k) numberK142498

Submission

Device name: MAGNIFY and MAGNIFY-S Spacers
Applicant: Globus Medical, Inc.
Audubon, PA, US
Received: September 5, 2014
Decision date: February 26, 2015
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
K254043	TRIVANCE Hip StemLPH · Traditional	08/04/2026SE
K262251	ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert)JWH · Special	07/31/2026SE
K253739	SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5…NKB · Traditional	05/07/2026SE
K253401	SCRIPT Implant SystemOVD · Traditional	04/29/2026SE
K261043	AUTOBAHN Nailing SystemHSB · Special	04/24/2026SE
K252166	RIB LINK Fixation SystemHRS · Traditional	02/26/2026SE
K253876	HEDRON Cervical Spacers (HEDRON C-MIS Spacer)OVE · Special	12/22/2025SE
K250599	ExcelsiusGPS InstrumentsOLO · Traditional	11/05/2025SE
K251161	ANTHEM® Fracture SystemHRS · Traditional	08/18/2025SE
K241525	ExcelsiusXRSBF · Traditional	07/08/2025SE

Questions and answers

When was MAGNIFY and MAGNIFY-S Spacers cleared by the FDA?

MAGNIFY and MAGNIFY-S Spacers (K142498) received a 510(k) decision of Substantially Equivalent on February 26, 2015, 174 days after the submission was received.

What is the product code of K142498?

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.