Medyssy LT Cage System

Q: What is the product code of K121246?

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) K121246 · Medyssey Co, Ltd.

Substantially Equivalent

510(k) numberK121246

Submission

Device name: Medyssy LT Cage System
Applicant: Medyssey Co, Ltd.
Skokie, IL, US
Received: April 25, 2012
Decision date: June 15, 2012
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

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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
K260036	NeckTune 3D SA Cervical CageOVE · Traditional	06/15/2026SE
K242806	Medyssey Navigation SystemOLO · Traditional	04/16/2025SE
K121670	Medyssey Cannulated Pedicle ScrewNKB · Traditional	01/25/2013SE
K121320	C7 Anterior Cervical Intervertebral Fusion CageODP · Traditional	08/10/2012SE
K110284	Novel III Spinal Fixation and Adjustable Bridge SystemMNI · Special	06/08/2011SE
K110283	Zenius Spinal SystemMNI · Special	05/19/2011SE
K110067	LP CageMAX · Traditional	04/08/2011SE
K103272	Zenius Spinal SystemMNI · Special	12/29/2010SE
K103147	Novel III Spinal Fixation and Adjustable Bridge SystemMNI · Special	12/16/2010SE
K093104	Medyssey Co., Ltd., Zenius Spinal SystemMNI · Traditional	06/25/2010SE

Questions and answers

When was Medyssy LT Cage System cleared by the FDA?

Medyssy LT Cage System (K121246) received a 510(k) decision of Substantially Equivalent on June 15, 2012, 51 days after the submission was received.

What is the product code of K121246?

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.