Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Premia Spine with 6 510(k) clearances and 1 device recall. The most recent is a device recall dated Jul 16, 2025: TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS ….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jul 16, 2025 | TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.Class II · Potential for missing pins at tip of inserter. | Device recalls |
| Nov 21, 2023 | ProMIS Extension Rod SystemK232719 · NKB | 510(k) clearances |
| Jul 7, 2023 | ProMIS™ Fixation SystemK231844 · NKB | 510(k) clearances |
| Oct 8, 2019 | Premia Spine XL InstrumentsK191854 · OLO | 510(k) clearances |
| Nov 13, 2018 | VersaLink™ Fixation SystemK182598 · NKB | 510(k) clearances |
| Feb 2, 2017 | ProMIS™ Fixation SystemK170061 · NKB | 510(k) clearances |
| Jul 17, 2015 | ProMIS Fixation SystemK150380 · NKB | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
