Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medicrea — 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) |
|---|---|---|---|---|---|
| K100484 | IMPIX MANTA CERVICAL INTERBODY DEVICE | Medicrea | 2010-03-16 | 26 | 1 |
| K062136 | PASS 2 SPINAL SYSTEM | Medicrea | 2006-10-06 | 72 | 0 |
| K050490 | OSMOSYS CALCIUM PHOSPHATE CERAMIC BONE FILLER | Medicrea | 2005-04-11 | 45 | 0 |
| K032094 | PASSMED SPINAL SYSTEM | Medicrea | 2003-11-14 | 130 | 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