Eminent Spine 3D Titanium Pedicle Screw System
FDA 510(k) K241663 · Eminent Spine
510(k) numberK241663
Submission
- Device name
- Eminent Spine 3D Titanium Pedicle Screw System
- Applicant
- Eminent Spine
Plano, TX, US - Received
- June 7, 2024
- Decision date
- April 28, 2025
- 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 |
|---|---|---|
| K250894 | Eminent Spine Posterior SI SystemOUR · Traditional | 10/07/2025SE |
| K242069 | Eminent Spine Scoliosis Deformity Pedicle Screw SystemNKB · Special | 09/03/2024SE |
| K240505 | Eminent Spine SI Screw SystemOUR · Traditional | 06/04/2024SE |
| K230219 | Eminent Spine 3D Lumbar Interbody Fusion SystemsMAX · Traditional | 05/16/2023SE |
| K212701 | Eminent Spine 3D Cervical Interbody Fusion SystemODP · Traditional | 02/06/2023SE |
| K221936 | Standalone ALIF Interbody Fusion SystemOVD · Traditional | 10/17/2022SE |
| K212853 | Cervical Stand-Alone SystemOVE · Traditional | 11/05/2021SE |
| K201979 | Cervical Plate SystemKWQ · Traditional | 08/25/2020SE |
| K143365 | Eminent Foot Plate SystemHRS · Traditional | 03/30/2015SE |
| K133194 | Diamond Rattlesnake SystemKWQ · Traditional | 06/26/2014SE |
Questions and answers
When was Eminent Spine 3D Titanium Pedicle Screw System cleared by the FDA?
Eminent Spine 3D Titanium Pedicle Screw System (K241663) received a 510(k) decision of Substantially Equivalent on April 28, 2025, 325 days after the submission was received.
What is the product code of K241663?
The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.