Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
N.M.B. Medical Applications, Ltd. — 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) |
|---|---|---|---|---|---|
| K102597 | PICCOLO COMPOSITE PLATE SYSTEM | N.M.B. Medical Applications, Ltd. | 2011-02-24 | 167 | 0 |
| K102369 | PICCOLO COMPOSITE NAILING SYSTEM | N.M.B. Medical Applications, Ltd. | 2011-01-31 | 164 | 1 |
| K100497 | QUANTUM IM COMPOSITE NAILING SYSTEM (QUANTUM NAILING SYSTEM) | N.M.B. Medical Applications, Ltd. | 2010-06-21 | 119 | 0 |
| K091425 | QUANTUM M COMPOSITE NAILING SYSTEM | N.M.B. Medical Applications, Ltd. | 2010-01-21 | 253 | 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