Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Premia Spine, Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
77 daysmedian FDA review time
154 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232719 | ProMIS Extension Rod System | Premia Spine, Ltd. | 2023-11-21 | 77 | 0 |
| K231844 | ProMIS™ Fixation System | Premia Spine, Ltd. | 2023-07-07 | 15 | 0 |
| K191854 | Premia Spine XL Instruments | Premia Spine, Ltd. | 2019-10-08 | 90 | 0 |
| K182598 | VersaLink™ Fixation System | Premia Spine, Ltd. | 2018-11-13 | 54 | 0 |
| K170061 | ProMIS™ Fixation System | Premia Spine, Ltd. | 2017-02-02 | 27 | 0 |
| K150380 | ProMIS Fixation System | Premia Spine, Ltd. | 2015-07-17 | 154 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda