Reliance Lumbar IBF System

Q: What is the product code of K183049?

The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.

FDA 510(k) K183049 · Reliance Medical Systems, LLC

Substantially Equivalent

510(k) numberK183049

Submission

Device name: Reliance Lumbar IBF System
Applicant: Reliance Medical Systems, LLC
Bountiful, UT, US
Received: November 2, 2018
Decision date: February 15, 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: MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3080
Specialty: Orthopedic
Implant: Yes

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other 510(k)s with product code MAX

510(k)	Device	Applicant	Decision
K261049	Scala® TLMAX · Traditional	Spineart SA	08/20/2026SE
K261430	TruLift Expandable SystemMAX · Traditional	Life Spine, Inc.	07/28/2026SE
K253011	Catalyft PL Expandable Interbody SystemMAX · Traditional	Medtronic Sofamor Danek USA, Inc.	07/17/2026SE
K261020	Symmetrix L Spinal SystemMAX · Traditional	Medtronic Sofamor Danek USA, Inc.	07/14/2026SE
K253420	Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…MAX · Traditional	SeaSpine Orthopedics Corporation	07/01/2026SE
K253151	Fule Interbody Fusion Cage SystemMAX · Traditional	Beijing Fule Science & Technology Development…	06/15/2026SE
K261159	Exceed® Biplanar Expandable Interbody SystemMAX · Traditional	Spine Wave, Inc.	05/29/2026SE
K253894	BMD Titanium Spinal Fusion SystemMAX · Traditional	Global Biomedica s.r.o.	05/28/2026SE
K260506	Ventana® P/T Lumbar Interbody SystemMAX · Traditional	Spinal Elements, Inc.	05/15/2026SE
K260837	VersaLift Expandable SystemMAX · Traditional	Life Spine, Inc.	05/12/2026SE

More from Life Spine, Inc.

510(k)	Device	Decision
K202266	Reliance Cervical IBF SystemODP · Traditional	03/29/2022SE
K210874	Reliance Spinal Screw SystemNKB · Special	05/13/2021SE
K181118	Reliance Lumbar IBF SystemOVD · Traditional	01/09/2019SE
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 (K183049) received a 510(k) decision of Substantially Equivalent on February 15, 2019, 105 days after the submission was received.

What is the product code of K183049?

The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.