BluEX Cervical Expandable Cage System
FDA 510(k) K260840 · L&K BIOMED Co., Ltd.
510(k) numberK260840
Submission
- Device name
- BluEX Cervical Expandable Cage System
- Applicant
- L&K BIOMED Co., Ltd.
Yongin-Si, KR - Received
- March 16, 2026
- Decision date
- May 16, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ODP – Intervertebral Fusion Device With Bone Graft, Cervical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Other 510(k)s with product code ODP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262595 | VariLift-C Cervical Interbody Fusion SystemODP · Special | Wenzel Spine, Inc. | 08/26/2026SE |
| K262489 | BluEX Cervical Expandable Cage SystemODP · Special | L&K BIOMED Co., Ltd. | 08/18/2026SE |
| K253041 | 3d Cage CervicalODP · Traditional | Fims Co., Ltd. | 07/23/2026SE |
| K262061 | Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…ODP · Special | Stryker Spine | 07/17/2026SE |
| K254130 | C.A. Medical Interbody Fusion SystemODP · Special | C.A. Medical, LLC | 07/08/2026SE |
| K260850 | Osteomni Spinal Cages SystemODP · Traditional | Osteomni, Inc. | 05/12/2026SE |
| K260549 | ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemODP · Special | Zsfab, Inc. | 04/24/2026SE |
| K253260 | ORIO-3D Cage SystemODP · Traditional | SpineCraft | 04/16/2026SE |
| K260340 | HC Biologics Osteopoint PEEK Cages, HC Biologics Osteopoint Cervical PEEK Cages, HC…ODP · Traditional | HC Biologics, LLC | 04/13/2026SE |
| K242303 | Mod-CODP · Traditional | Orthomod, LLC | 04/01/2026SE |
More from Orthomod, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K262489 | BluEX Cervical Expandable Cage SystemODP · Special | 08/18/2026SE |
| 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 |
| K240201 | PathLoc SI Joint Fusion SystemOUR · Special | 02/23/2024SE |
Questions and answers
When was BluEX Cervical Expandable Cage System cleared by the FDA?
BluEX Cervical Expandable Cage System (K260840) received a 510(k) decision of Substantially Equivalent on May 16, 2026, 61 days after the submission was received.
What is the product code of K260840?
The FDA product code is ODP – Intervertebral Fusion Device With Bone Graft, Cervical, a Class II (moderate risk) device regulated under 21 CFR 888.3080.