Dark Star Deformity Pedicle Screw System
Republic Spine, LLC
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3011796723 | 3011796723 | REPUBLIC SPINE | 1 | N | 2026-01-01 | 100 NE Third Avenue STE 120 Fort Lauderdale FL US 33301 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| B075102001400 | Dark Star Navigation - Dark Star Navigation Triple Lead Tap - Ø4.0mm | 561-334-2421 | james@rspine.com |
| B07511002428S0606T0 | Restore Lumbar Interbody Fusion System - Titanium Restore Lumbar Transforaminal Lumbar Lordotic Interbody Cage, 28mm long x 9mm wide x 6mm high x 6° | 888-855-0704 | james@rspine.com |
| B07511002428S0706T0 | Restore Lumbar Interbody Fusion System - Titanium Restore Lumbar Transforaminal Lumbar Lordotic Interbody Cage, 28mm long x 9mm wide x 7mm high x 6° | 888-855-0704 | james@rspine.com |
| B07511002428S0806T0 | Restore Lumbar Interbody Fusion System - Titanium Restore Lumbar Transforaminal Lumbar Lordotic Interbody Cage, 28mm long x 9mm wide x 8mm high x 6° | 888-855-0704 | james@rspine.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 185881 | 1785534023 | K223096 | Dark Star Deformity Pedicle Screw System | NKB | 2023-05-26 |
| 185881 | 1862936075 | K212028 | Dark Star Navigation Instrument System | OLO | 2021-09-27 |
| 185881 | 1816070166 | K190889 | Republic Spine Restore Cervical Interbody Fusion System | ODP | 2019-06-19 |
| 185881 | 1991362677 | K190398 | Republic Spine Restore Intervertebral Body Fusion System | MAX | 2019-09-12 |
| 185881 | 1122106713 | K181495 | Republic Spine Dark Star Spinal System | NKB | 2018-07-25 |
| 185881 | 1590390230 | K150283 | Republic Spine Dark Star Spinal System | MNH | 2015-04-29 |
Republic Spine, LLC
Republic Spine, LLC
Republic Spine, LLC
Republic Spine LLC
Republic Spine, L.L.C.
Republic Spine, L.L.C.
REPUBLIC SPINE, LLC
2026-05-14
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