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 | K150283 |
| 510k Number | K150283 |
| Device Name: | Republic Spine Dark Star Spinal System |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | REPUBLIC SPINE, LLC 3200 NE 14TH STREET CAUSEWAY SUITE 250 Pompano Beach, FL 33062 |
| Contact | Rusty Mccarver |
| Correspondent | Cheryl L Wagoner Wagoner Consulting LLC PO Box 15729 Wilmington, NC 28408 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-05 |
| Decision Date | 2015-04-29 |
| Summary: | summary |