LEO Spinal System
FDA 510(k) K252542 · ZheJiang Decans Medical Devices Co., Ltd.
510(k) numberK252542
Submission
- Device name
- LEO Spinal System
- Applicant
- ZheJiang Decans Medical Devices Co., Ltd.
Jiaxing City, CN - Received
- August 12, 2025
- Decision date
- April 29, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NKB – Thoracolumbosacral Pedicle Screw System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.
Other 510(k)s with product code NKB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262828 | KHEIRON® Spinal Fixation System, including patient specific K-RODNKB · Special | S.M.A.I.O | 09/04/2026SE |
| K260362 | QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS…NKB · Traditional | MANTIZ Co., Ltd. | 07/24/2026SE |
| K253943 | Tiger 2 SystemNKB · Traditional | Zavation Medical Products, LLC | 07/24/2026SE |
| K261284 | Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemNKB · Traditional | Alphatec Spine, Inc. | 07/14/2026SE |
| K253802 | KHEIRON® Spinal Fixation System, including patient specific K-RODNKB · Special | S.M.A.I.O | 07/01/2026SE |
| K253045 | Socko Vimax Spinal Fixation SystemNKB · Traditional | Socko Medical Co., Ltd. | 06/17/2026SE |
| K251251 | ChanPin Pedicle Screw Spinal SystemNKB · Traditional | Chanpin Medtak Co., Ltd. | 06/09/2026SE |
| K260989 | Varion Thoracolumbar Fixation SystemNKB · Traditional | Kyocera Medical Technologies Inc. (KMTI) | 05/15/2026SE |
| K253739 | SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5…NKB · Traditional | Globus Medical, Inc. | 05/07/2026SE |
| K261130 | AccelFix Spinal Fixation SystemNKB · Special | L&K BIOMED Co., Ltd. | 05/05/2026SE |
More from L&K BIOMED Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K253046 | HERA Interlocking Intramedullary Nailing SystemHSB · Traditional | 06/16/2026SE |
| K253195 | TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsNKG · Traditional | 06/02/2026SE |
| K253130 | Dione PEEK Screw SystemMBI · Traditional | 05/27/2026SE |
| K252930 | AQUA Laminoplasty SystemsNQW · Traditional | 05/27/2026SE |
| K252776 | ARIES Anterior Cervical Plate SystemsKWQ · Traditional | 05/14/2026SE |
| K253213 | SAGI Cervical Cage SystemOVE · Traditional | 04/20/2026SE |
| K252774 | Uni-C Cervical Cage SystemOVE · Traditional | 04/15/2026SE |
| K243665 | Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System…MBI · Traditional | 01/31/2025SE |
| K242195 | Gemini Cervical Fusion Cage SystemODP · Traditional | 11/04/2024SE |
| K242267 | Gemini Medical Cage SystemMAX · Traditional | 10/08/2024SE |
Questions and answers
When was LEO Spinal System cleared by the FDA?
LEO Spinal System (K252542) received a 510(k) decision of Substantially Equivalent on April 29, 2026, 260 days after the submission was received.
What is the product code of K252542?
The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.