Republic Spine Dark Star Spinal System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K201420 FDA 510(k)
- FDA Product Code
- NKB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3070 FDA 510(k)
- Regulation Number
- 888.3070 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Republic Spine Dark Star Spinal System is a posterior, non-cervical pedicle fixation system designed to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. It is indicated for the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine (T1-S1), including severe spondylolisthesis.
The system is supplied as a sterile, single-use device and is intended for use in a hospital or surgical setting. It has received FDA 510(k) clearance under K201420 with product code NKB and is classified under the Orthopedic advisory committee (OR). No MRI safety information is provided in the data.
Frequently asked questions
What is the Republic Spine Dark Star Spinal System used for?
The Dark Star Spinal System is a posterior, non-cervical pedicle fixation system designed to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. It treats acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine (T1-S1), including severe spondylolisthesis.
How is the Republic Spine Dark Star Spinal System supplied?
The system is supplied as a sterile, single-use device intended for use in a hospital or surgical setting. It is not designed for reuse and should be handled according to sterile protocol during surgical procedures.
What regulatory approvals does the Republic Spine Dark Star Spinal System have?
The system has received FDA 510(k) clearance under K201420 with product code NKB and is classified under the Orthopedic advisory committee (OR). This clearance indicates it is substantially equivalent to predicate devices for its intended use.
Which spinal segments can be treated with the Dark Star Spinal System?
The Dark Star Spinal System is indicated for treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine (T1-S1), including severe spondylolisthesis in skeletally mature patients. It is not designed for cervical spine applications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Republic Spine | MIS & Deformity Spinal Instrumentation | Boca Raton, Republic Spine Dark Star Spinal System (K150283) - Innolitics, Darkstar | Republic Spine | Boca Raton
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201420 | Class II | Active |
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Manufacturer
- Manufacturer
- Republic Spine, LLC
Sources (1)
- FDA 510(k) K201420 24 fields · synced Sep 28, 2026