Reliance Lumbar IBF System

Q: What is the product code of K181118?

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) K181118 · Reliance Medical Systems

Substantially Equivalent

510(k) numberK181118

Submission

Device name: Reliance Lumbar IBF System
Applicant: Reliance Medical Systems
Bountiful, UT, US
Received: April 27, 2018
Decision date: January 9, 2019
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
K202266	Reliance Cervical IBF SystemODP · Traditional	03/29/2022SE
K210874	Reliance Spinal Screw SystemNKB · Special	05/13/2021SE
K183049	Reliance Lumbar IBF SystemMAX · Special	02/15/2019SE
K180687	Reliance Lumber IBF SystemMAX · Special	05/15/2018SE
K173283	Reliance Lumbar IBF SystemMAX · Special	01/19/2018SE
K173102	Reliance Cervical IBF SystemODP · Special	12/29/2017SE
K172489	Reliance Cervical IBF SystemODP · Special	09/07/2017SE
K162066	Reliance Spinal Screw SystemMNH · Traditional	12/02/2016SE
K160463	Reliance Lumbar IBF SystemMAX · Special	05/20/2016SE
K152131	Reliance Spinal Screw SystemMNI · Special	09/17/2015SE

Questions and answers

When was Reliance Lumbar IBF System cleared by the FDA?

Reliance Lumbar IBF System (K181118) received a 510(k) decision of Substantially Equivalent on January 9, 2019, 257 days after the submission was received.

What is the product code of K181118?

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.