Mobis, Moval, Semial, Tetrismodel PEEK and Titanium, Kimba Model Standard and Mini

Q: What is the product code of K111792?

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) K111792 · Signus Medizintechnik GmbH

Substantially Equivalent

510(k) numberK111792

Submission

Device name: Mobis, Moval, Semial, Tetrismodel PEEK and Titanium, Kimba Model Standard and Mini
Applicant: Signus Medizintechnik GmbH
Chesterland, OH, US
Received: June 27, 2011
Decision date: March 5, 2012
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
K243188	Cylox® STOVE · Traditional	02/11/2025SE
K241438	Signus Tetris St; Signus Tetris R StMAX · Traditional	09/11/2024SE
K220658	COSY Cervicothoracic Occipital Rod-Screw SystemNKG · Traditional	11/18/2022SE
K212755	SIGNUS SACRONAIL® Transsacral Stabilization SystemHWC · Traditional	03/10/2022SE
K203327	VERTACONNECT TLIF CageMAX · Traditional	01/25/2021SE
K151704	Diplomat® Spinal SystemNKB · Traditional	04/13/2016SE
K141405	Mobis II ST Spinal ImplantMAX · Traditional	09/16/2014SE
K123758	Tasmin RMQP · Traditional	01/14/2014SE
K131372	Mobis IIMAX · Traditional	07/02/2013SE
K122317	Tetris IIMAX · Special	08/29/2012SE

Questions and answers

When was Mobis, Moval, Semial, Tetrismodel PEEK and Titanium, Kimba Model Standard and Mini cleared by the FDA?

Mobis, Moval, Semial, Tetrismodel PEEK and Titanium, Kimba Model Standard and Mini (K111792) received a 510(k) decision of Substantially Equivalent on March 5, 2012, 252 days after the submission was received.

What is the product code of K111792?

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.