Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
SpineCraft — 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) |
|---|---|---|---|---|---|
| K253260 | ORIO-3D Cage System | SpineCraft | 2026-04-16 | 199 | 0 |
| K260015 | ANTERIS Thoracolumbar Plate System | SpineCraft | 2026-03-04 | 58 | 0 |
| K090887 | ORIO-C CERVICAL, ORIO-TL TLIF, ORIO-PL PLIF, ORIO-AL ALIF IN | SpineCraft | 2009-10-30 | 213 | 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