4CIS® Chiron Spinal Fixation System
FDA 510(k) K231655 · Solco Biomedical Co., Ltd.
510(k) numberK231655
Submission
- Device name
- 4CIS® Chiron Spinal Fixation System
- Applicant
- Solco Biomedical Co., Ltd.
Pyeongtaek-Si, KR - Received
- June 6, 2023
- Decision date
- November 26, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K203233 | 4CIS Chiron Spinal Fixation SystemNKB · Special | 06/01/2022SE |
| K192044 | 4CIS Marlin PEEK ACIF CageODP · Traditional | 12/19/2019SE |
| K190563 | 4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage…MAX · Traditional | 09/18/2019SE |
| K190471 | 4CIS® Chiron Spinal Fixation SystemNKB · Traditional | 07/24/2019SE |
| K182489 | 4CIS® Pinehurst Anterior Cervical Plate systemKWQ · Traditional | 01/16/2019SE |
| K162402 | 4CIS® Marlin ACIF Cage SystemODP · Traditional | 02/16/2017SE |
| K121615 | 4CIS Vane Spine SystemMNI · Special | 08/15/2012SE |
| K102458 | 4CIS Solar Spine System and 4CIS Apollon Spine SystemMNH · Special | 06/13/2011SE |
| K101818 | 4CIS Vane Spine SystemMNH · Traditional | 02/11/2011SE |
| K092162 | 4CIS PEEK, Plif and Tlif Cage SystemMAX · Traditional | 01/06/2010SE |
Questions and answers
When was 4CIS® Chiron Spinal Fixation System cleared by the FDA?
4CIS® Chiron Spinal Fixation System (K231655) received a 510(k) decision of Substantially Equivalent on November 26, 2024, 539 days after the submission was received.
What is the product code of K231655?
The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.