Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pantheon Spinal — 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) |
|---|---|---|---|---|---|
| K241494 | Pantheon Pedicle Screw and Iliac Bolt Fixation System | Pantheon Spinal | 2024-07-26 | 59 | 0 |
| K203003 | Pantheon IBFD | Pantheon Spinal | 2021-07-07 | 279 | 0 |
| K181548 | Pantheon Spinal Pontus Interbody Fusion Device | Pantheon Spinal | 2019-12-16 | 552 | 0 |
| K113781 | PANTHEON SPINAL IBFD SYSTEM | Pantheon Spinal | 2013-04-26 | 491 | 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