Republic Spine, LLC: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Republic Spine, LLC” (first 2015, latest 2023), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 90 days. Since 2017 the median was 148 days, against 91 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 1 | 83 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 49 |
| 2019 | 2 | 140 |
| 2020 | 0 | — |
| 2021 | 2 | 185 |
| 2022 | 0 | — |
| 2023 | 1 | 238 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Republic Spine, LLC took a median 148 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 91 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 3 | 3 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 | 1 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 1 | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 | 1 |
| OLO | Orthopedic Stereotaxic Instrument | 1 | 1 |
Review panels
- Orthopedic (7)
Most recent Republic Spine, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K223096 | Dark Star Deformity Pedicle Screw System | NKB | 2023-05-26 | 238 |
| K212028 | Dark Star Navigation Instrument System | OLO | 2021-09-27 | 90 |
| K201420 | Republic Spine Dark Star Spinal System | NKB | 2021-03-05 | 280 |
| K190398 | Republic Spine Restore Intervertebral Body Fusion System | MAX | 2019-09-12 | 205 |
| K190889 | Republic Spine Restore Cervical Interbody Fusion System | ODP | 2019-06-19 | 75 |
| K181495 | Republic Spine Dark Star Spinal System | NKB | 2018-07-25 | 49 |
| K150283 | Republic Spine Dark Star Spinal System | MNH | 2015-04-29 | 83 |
Recalls
openFDA lists no recalls under a recalling firm named Republic Spine, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Republic Spine, LLC?
FDA lists 7 510(k) clearances under the applicant name “Republic Spine, LLC” (first 2015, latest 2023), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Republic Spine, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Republic Spine, LLC is 90 days. Since 2017: 148 days, versus 91 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Republic Spine, LLC?
The most frequent FDA product codes under this applicant name are NKB (Thoracolumbosacral Pedicle Screw System, 3); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 1); MNH (Orthosis, Spondylolisthesis Spinal Fixation, 1).
Next steps
- See all 7 Republic Spine, LLC clearances with predicates and recalls
- Run predicate analysis for product code NKB, Republic Spine, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.