CoreLink Midline Fixation System
FDA 510(k) K210539 · Corelink, LLC
510(k) numberK210539
Submission
- Device name
- CoreLink Midline Fixation System
- Applicant
- Corelink, LLC
St. Louis, MO, US - Received
- February 24, 2021
- Decision date
- April 15, 2021
- 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 |
|---|---|---|
| K231743 | F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…MAX · Traditional | 12/08/2023SE |
| K231494 | CoreLink Robotic Navigation InstrumentsOLO · Traditional | 10/27/2023SE |
| K232116 | CoreLink Navigation InstrumentsOLO · Special | 08/16/2023SE |
| K230329 | F3D Interbody SystemODP · Traditional | 06/06/2023SE |
| K230880 | CoreLink Navigation InstrumentsOLO · Special | 05/02/2023SE |
| K223708 | Entasis 3D Dual-Lead Sacroiliac Implant SystemOUR · Traditional | 03/21/2023SE |
| K221776 | NextGen Pedicle Screw SystemNKB · Traditional | 08/09/2022SE |
| K220973 | CoreLink Navigation InstrumentsOLO · Traditional | 06/01/2022SE |
| K211417 | F3D-C2 Cervical Stand-Alone SystemOVE · Traditional | 02/04/2022SE |
| K214059 | CoreLink Navigation InstrumentsOLO · Special | 01/19/2022SE |
Questions and answers
When was CoreLink Midline Fixation System cleared by the FDA?
CoreLink Midline Fixation System (K210539) received a 510(k) decision of Substantially Equivalent on April 15, 2021, 50 days after the submission was received.
What is the product code of K210539?
The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.