Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Spine Smith Holdings, LLC · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K193465 | CorticaLINK Spinal Fusion Platform | Spine Smith Holdings, LLC | 2020-01-10 | 25 | 0 |
| K180807 | Celling Aspiration Needle | Spine Smith Holdings, LLC | 2018-05-24 | 57 | 0 |
| K141537 | IN:C2 SPINAL FIXATION SYSTME | Spine Smith Holdings, LLC | 2014-11-25 | 168 | 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