Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Scient'X USA, 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) |
|---|---|---|---|---|---|
| K081548 | ANTERIOR BUTTRESS PLATE | Scient'X USA, Inc. | 2009-01-29 | 241 | 0 |
| K080588 | SCIENT'X TRIBECA VBR | Scient'X USA, Inc. | 2008-05-30 | 88 | 0 |
| K053292 | DAVANTIS/ANTELYS VERTEBRAL BODY REPLACEMENTS | Scient'X USA, Inc. | 2006-01-19 | 55 | 0 |
| K031290 | MODIFICATION TO EASYS TRANSVERSE CONNECTION | Scient'X USA, Inc. | 2003-05-13 | 20 | 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