Shell Cage, Wave Cage, Loop Cage

Q: What is the product code of K080401?

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) K080401 · Advanced Medical Technologies AG

Substantially Equivalent

510(k) numberK080401

Submission

Device name: Shell Cage, Wave Cage, Loop Cage
Applicant: Advanced Medical Technologies AG
Round Rock, TX, US
Received: February 14, 2008
Decision date: May 9, 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
K121333	Wave D CageMAX · Traditional	06/29/2012SE
K121332	Loop CageMAX · Traditional	06/29/2012SE
K121330	Wave O CageMAX · Traditional	06/29/2012SE
K121288	Fuse CageMAX · Traditional	06/29/2012SE
K103573	ARTS2 Spinal Fixation SystemMNH · Traditional	12/28/2011SE
K100945	Fuse Plif CafeMAX · Traditional	02/09/2011SE
K053473	Maestro MDTL Laser SystemILY · Traditional	02/03/2006SE
K043353	Omega Excel/Xp Laser SystemNHN · Traditional	07/01/2005SE
K033148	Art Anterior Spinal SystemKWQ · Traditional	04/12/2004SE
K033150	Art Posterior Spinal SystemMNI · Traditional	03/01/2004SE

Questions and answers

When was Shell Cage, Wave Cage, Loop Cage cleared by the FDA?

Shell Cage, Wave Cage, Loop Cage (K080401) received a 510(k) decision of Substantially Equivalent on May 9, 2008, 85 days after the submission was received.

What is the product code of K080401?

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.