Premia Spine, Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Premia Spine, Ltd.” (first 2015, latest 2023), plus 1 PMA decision, across 3 product codes in 1 review panel. Median 510(k) review time under this name: 66 days. Since 2017 the median was 54 days, against 88 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 | 154 |
| 2016 | 0 | — |
| 2017 | 1 | 27 |
| 2018 | 1 | 54 |
| 2019 | 1 | 90 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 2 | 46 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Premia Spine, Ltd. took a median 54 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 88 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 5 | 5 |
| OLO | Orthopedic Stereotaxic Instrument | 1 | 1 |
| QWK | Prosthesis, Posterior Spinal Elements | 1 | 0 |
Review panels
- Orthopedic (7)
Most recent Premia Spine, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232719 | ProMIS Extension Rod System | NKB | 2023-11-21 | 77 |
| K231844 | ProMIS Fixation System | NKB | 2023-07-07 | 15 |
| K191854 | Premia Spine XL Instruments | OLO | 2019-10-08 | 90 |
| K182598 | VersaLink Fixation System | NKB | 2018-11-13 | 54 |
| K170061 | ProMIS Fixation System | NKB | 2017-02-02 | 27 |
| K150380 | ProMIS Fixation System | NKB | 2015-07-17 | 154 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P220002 | PMA | TOPS System | 2023-06-15 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2025-07-16.
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.
Device clinical trials
An industry sponsor named Premia Spine, Ltd. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03012776: A Pivotal Study of the Premia Spine TOPS™ System (Completed, started 2017-07-17)
Frequently asked questions
How many FDA 510(k) clearances are listed under Premia Spine, Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Premia Spine, Ltd.” (first 2015, latest 2023), plus 1 PMA decision, across 3 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 Premia Spine, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Premia Spine, Ltd. is 66 days. Since 2017: 54 days, versus 88 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Premia Spine, Ltd.?
The most frequent FDA product codes under this applicant name are NKB (Thoracolumbosacral Pedicle Screw System, 5); OLO (Orthopedic Stereotaxic Instrument, 1); QWK (Prosthesis, Posterior Spinal Elements, 1).
Next steps
- See all 6 Premia Spine, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code NKB, Premia Spine, Ltd.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.