PathLoc-TA Expandable Lumbar Cage System

Q: What is the product code of K223474?

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) K223474 · L&K BIOMED Co., Ltd.

Substantially Equivalent

510(k) numberK223474

Submission

Device name: PathLoc-TA Expandable Lumbar Cage System
Applicant: L&K BIOMED Co., Ltd.
Yongin-Si, KR
Received: November 18, 2022
Decision date: January 13, 2023
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
K262489	BluEX Cervical Expandable Cage SystemODP · Special	08/18/2026SE
K260840	BluEX Cervical Expandable Cage SystemODP · Traditional	05/16/2026SE
K261112	CastleLoc-P Anterior Cervical Plate SystemKWQ · Special	05/06/2026SE
K261130	AccelFix Spinal Fixation SystemNKB · Special	05/05/2026SE
K260448	CastleLoc Pectus Bar SystemHRS · Special	03/19/2026SE
K251940	PathLoc Lumbar Plate SystemKWQ · Traditional	03/03/2026SE
K251741	PathLoc Lumbar Interbody Fusion Cage SystemMAX · Special	07/08/2025SE
K250892	CastleLoc Pectus Bar SystemHRS · Special	04/25/2025SE
K243357	CastleLoc Pectus Bar SystemHRS · Traditional	02/27/2025SE
K242829	BluEX Lumbar Expandable Cage SystemMAX · Traditional	10/23/2024SE

Questions and answers

When was PathLoc-TA Expandable Lumbar Cage System cleared by the FDA?

PathLoc-TA Expandable Lumbar Cage System (K223474) received a 510(k) decision of Substantially Equivalent on January 13, 2023, 56 days after the submission was received.

What is the product code of K223474?

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.