Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Sign Fracture Care International · 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) |
|---|---|---|---|---|---|
| K163589 | SIGN IM Nail | Sign Fracture Care International | 2017-07-20 | 212 | 0 |
| K153759 | SIGN Compression Screw System | Sign Fracture Care International | 2016-02-25 | 57 | 0 |
| K152757 | SIGN Hip Construct (SHC) | Sign Fracture Care International | 2015-11-13 | 50 | 0 |
| K122823 | SIGN PEDIATRIC FIN NAIL | Sign Fracture Care International | 2013-04-16 | 214 | 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