Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Spinal Resources, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252461 | Swedge™ Pedicle Screw Fixation System Bezier Rod | Spinal Resources, Inc. | 2026-01-13 | 161 | 0 |
| K230482 | Swedge™ Pedicle Screw Fixation System | Spinal Resources, Inc. | 2023-03-23 | 29 | 0 |
| K170045 | Swedge™ Pedicle Screw Fixation System | Spinal Resources, Inc. | 2017-06-26 | 172 | 0 |
| K152662 | S-Wire | Spinal Resources, Inc. | 2016-03-09 | 174 | 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