Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Leibinger GmbH — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K954030 | BONE-LOCK | Leibinger GmbH | 1997-11-14 | 809 | 0 |
| K946033 | LEIBINGER STEREOPLAN PLUS STEROTACTIC TREATMENT PLAN ING SOF | Leibinger GmbH | 1995-09-01 | 266 | 0 |
| K924685 | STP COMPLETE MODULE SET AND MASK FIXATION SYSTEM | Leibinger GmbH | 1994-09-16 | 730 | 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