Lanx Intervertebral Body Fusion Device

Q: What is the product code of K073144?

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) K073144 · Lanx, LLC

Substantially Equivalent

510(k) numberK073144

Submission

Device name: Lanx Intervertebral Body Fusion Device
Applicant: Lanx, LLC
Broomfield, CO, US
Received: November 7, 2007
Decision date: January 24, 2008
Decision: Substantially Equivalent (SESE)
Type: Traditional 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
K131547	Lanx Fusion SystemOVD · Special	07/12/2013SE
K131156	Lanx Spinal Fixation SystemKWP · Special	05/24/2013SE
K123767	Lanx Fusion System- SAOVD · Traditional	03/18/2013SE
K121316	Lanx Spinal Fization SystemNKB · Traditional	09/10/2012SE
K122145	Lanx Spinal Fixation SystemNKB · Special	08/17/2012SE
K121940	Lanx Spinal Fixation SystemNKB · Special	08/02/2012SE
K120399	Lanx Spinal Fixation SystemNKB · Special	03/09/2012SE
K113434	Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)NKB · Special	12/19/2011SE
K112388	Lanx Cervical SAOVE · Traditional	12/16/2011SE
K103091	Lanx Spinal Fixation SystemKWP · Special	04/15/2011SE

Questions and answers

When was Lanx Intervertebral Body Fusion Device cleared by the FDA?

Lanx Intervertebral Body Fusion Device (K073144) received a 510(k) decision of Substantially Equivalent on January 24, 2008, 78 days after the submission was received.

What is the product code of K073144?

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.