PathLoc Lumbar Interbody Fusion Cage System
FDA 510(k) K251741 · L&K BIOMED Co., Ltd.
510(k) numberK251741
Submission
- Device name
- PathLoc Lumbar Interbody Fusion Cage System
- Applicant
- L&K BIOMED Co., Ltd.
Yongin-Si, KR - Received
- June 6, 2025
- Decision date
- July 8, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| 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 |
| 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 |
| K240201 | PathLoc SI Joint Fusion SystemOUR · Special | 02/23/2024SE |
Questions and answers
When was PathLoc Lumbar Interbody Fusion Cage System cleared by the FDA?
PathLoc Lumbar Interbody Fusion Cage System (K251741) received a 510(k) decision of Substantially Equivalent on July 8, 2025, 32 days after the submission was received.
What is the product code of K251741?
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.