Republic Spine Dark Star Spinal System
FDA 510(k) K181495 · Republic Spine, LLC
510(k) numberK181495
Submission
- Device name
- Republic Spine Dark Star Spinal System
- Applicant
- Republic Spine, LLC
Boca Raton, FL, US - Received
- June 6, 2018
- Decision date
- July 25, 2018
- 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.
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| 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 |
|---|---|---|
| K223096 | Dark Star Deformity Pedicle Screw SystemNKB · Traditional | 05/26/2023SE |
| K212028 | Dark Star Navigation Instrument SystemOLO · Traditional | 09/27/2021SE |
| K201420 | Republic Spine Dark Star Spinal SystemNKB · Traditional | 03/05/2021SE |
| K190398 | Republic Spine Restore Intervertebral Body Fusion SystemMAX · Traditional | 09/12/2019SE |
| K190889 | Republic Spine Restore Cervical Interbody Fusion SystemODP · Traditional | 06/19/2019SE |
| K150283 | Republic Spine Dark Star Spinal SystemMNH · Traditional | 04/29/2015SE |
Questions and answers
When was Republic Spine Dark Star Spinal System cleared by the FDA?
Republic Spine Dark Star Spinal System (K181495) received a 510(k) decision of Substantially Equivalent on July 25, 2018, 49 days after the submission was received.
What is the product code of K181495?
The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.