Cortina [MAX] Lumbar Cage System

Q: What is the product code of K180431?

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) K180431 · Neurostructures, Inc.

Substantially Equivalent

510(k) numberK180431

Submission

Device name: Cortina [MAX] Lumbar Cage System
Applicant: Neurostructures, Inc.
Irvine, CA, US
Received: February 16, 2018
Decision date: March 22, 2018
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
K202190	Oculus-SA Lumbar Cage SystemOVD · Traditional	10/02/2020SE
K200115	Cavetto-SA Cervical Cage SystemOVE · Special	09/24/2020SE
K201769	Cavetto [MAX] Cervical Cage SystemODP · Traditional	09/03/2020SE
K200927	Transept Cervical Plate SystemKWQ · Traditional	07/24/2020SE
K192248	Cortina [MAX] Lumbar Cage SystemMAX · Special	11/25/2019SE
K182195	Arco-SA Lumbar Cage SystemOVD · Special	11/09/2018SE
K181590	Neurostructures Cavetto® [MAX] Cervical Cage SystemODP · Special	11/08/2018SE
K173082	Arco-SA Lumbar Cage SystemOVD · Traditional	03/29/2018SE
K172320	Neurostructures Cavetto® Cervical Cage SystemODP · Traditional	02/26/2018SE
K173077	Cavetto-SA Cervical Cage SystemOVE · Traditional	02/23/2018SE

Questions and answers

When was Cortina [MAX] Lumbar Cage System cleared by the FDA?

Cortina [MAX] Lumbar Cage System (K180431) received a 510(k) decision of Substantially Equivalent on March 22, 2018, 34 days after the submission was received.

What is the product code of K180431?

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.