Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Neoligaments, Ltd. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
483 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K941772 | CRADLE FIXATION DEVICE | Neoligaments, Ltd. | 1995-08-07 | 483 | 0 |
| K952543 | GRAFTOLOGER PGH & ACL RECONSTRUCTION INSTRUMENT SET | Neoligaments, Ltd. | 1995-06-22 | 35 | 0 |
| K935753 | THE GRAFTOLOGER | Neoligaments, Ltd. | 1994-04-25 | 150 | 0 |
| K930339 | REAMER BIT | Neoligaments, Ltd. | 1993-08-06 | 193 | 0 |
| K913461 | FASTLOK (STAPLE & BUCKLE) FIXATION SYSTEM | Neoligaments, Ltd. | 1991-10-15 | 71 | 0 |
| K911445 | FASTLOK (STAPLE AND BUCKLE) FIXATION SYSTEM | Neoligaments, Ltd. | 1991-06-28 | 86 | 0 |
| K904340 | FASTLOK (STAPLE AND BUCKLE) FIXATION SYSTEM | Neoligaments, Ltd. | 1990-10-19 | 29 | 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