Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Smv Scientific — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
128 daysmedian FDA review time
244 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K170021 | SMV Scientific Cannulated Screws | Smv Scientific | 2017-05-22 | 139 | 0 |
| K160946 | 4.0 and 6.5 Cancellous Bone Screw and Washer | Smv Scientific | 2016-12-05 | 244 | 0 |
| K160603 | SMV Scientific Schanz Screws | Smv Scientific | 2016-03-28 | 26 | 0 |
| K152000 | SMV Scientific Bone Plate and Screw System | Smv Scientific | 2015-11-25 | 128 | 0 |
| K150981 | SMV Scientific Bone Screws | Smv Scientific | 2015-06-23 | 70 | 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