The following data is part of a premarket notification filed by Republic Spine, Llc with the FDA for Republic Spine Dark Star Spinal System.
| Device ID | K201420 |
| 510k Number | K201420 |
| Device Name: | Republic Spine Dark Star Spinal System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Republic Spine, LLC 2424 N Federal Hwy, STE 257 Boca Raton, FL 33431 |
| Contact | James Doulgeris |
| Correspondent | James Doulgeris Republic Spine, LLC 2424 N Federal Hwy, STE 257 Boca Raton, FL 33431 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-29 |
| Decision Date | 2021-03-05 |