AnyPlus II Spinal Fixation System
FDA 510(k) K240350 · GS Medical Co., Ltd.
510(k) numberK240350
Submission
- Device name
- AnyPlus II Spinal Fixation System
- Applicant
- GS Medical Co., Ltd.
Cheongju-Si, KR - Received
- February 5, 2024
- Decision date
- April 3, 2024
- 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 |
|---|---|---|
| K243073 | AnyPlus Navigated Instruments SystemOLO · Traditional | 12/06/2024SE |
| K241738 | PYXIS 3D Titanium Cervical Cage systemODP · Traditional | 08/20/2024SE |
| K231808 | QUASAR Standalone ACIF SystemOVE · Special | 07/20/2023SE |
| K223868 | PYXIS 3D Titanium Cage SystemMAX · Traditional | 04/26/2023SE |
| K222041 | CYGNUS-C Standalone ACIF SystemOVE · Traditional | 02/09/2023SE |
| K221687 | Pegasus-X Expandable PLIF SystemMAX · Traditional | 07/27/2022SE |
| K211797 | TRACKER Plus Kyphoplasty SystemNDN · Traditional | 10/28/2021SE |
| K200592 | GS Medical AnyPlus PEEK Cage SystemODP · Traditional | 08/10/2020SE |
| K192335 | TRACKER Kyphoplasty SystemNDN · Traditional | 12/04/2019SE |
| K190170 | MVP Cervical Plate SystemKWQ · Traditional | 05/13/2019SE |
Questions and answers
When was AnyPlus II Spinal Fixation System cleared by the FDA?
AnyPlus II Spinal Fixation System (K240350) received a 510(k) decision of Substantially Equivalent on April 3, 2024, 58 days after the submission was received.
What is the product code of K240350?
The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.