Kleiner KG2 System

Q: When was Kleiner KG2 System cleared by the FDA?

Kleiner KG2 System (K211474) received a 510(k) decision of Substantially Equivalent on September 14, 2021, 125 days after the submission was received.

Q: What is the product code of K211474?

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) K211474 · BAAT Medical Products B.V.

Substantially Equivalent

510(k) numberK211474

Submission

Device name: Kleiner KG2 System
Applicant: BAAT Medical Products B.V.
Hengelo, NL
Received: May 12, 2021
Decision date: September 14, 2021
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
K254176	SinefixMBI · Special	03/16/2026SE
K251961	SDS Growing RodPGM · Traditional	01/15/2026SE
K220966	SinefixMBI · Traditional	03/08/2023SE
K201830	ANSER Clavicle PinHSB · Traditional	08/27/2020SE

Questions and answers

When was Kleiner KG2 System cleared by the FDA?

Kleiner KG2 System (K211474) received a 510(k) decision of Substantially Equivalent on September 14, 2021, 125 days after the submission was received.

What is the product code of K211474?

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.