Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Teknimed, S.A. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
147 daysmedian FDA review time
305 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K103433 | F20 | Teknimed, S.A. | 2011-01-03 | 40 | 0 |
| K090435 | VERTECEM | Teknimed, S.A. | 2009-12-21 | 305 | 0 |
| K083005 | NANGEL | Teknimed, S.A. | 2009-03-04 | 147 | 0 |
| K080873 | OPACITY + BONE CEMENT | Teknimed, S.A. | 2008-08-28 | 150 | 0 |
| K062102 | ODONCER | Teknimed, S.A. | 2007-04-16 | 266 | 0 |
| K043593 | SPINE-FIX BIOMIMETIC BONE CEMENT | Teknimed, S.A. | 2006-03-17 | 443 | 0 |
| K042911 | CEMENTEK LV | Teknimed, S.A. | 2004-12-27 | 67 | 0 |
| K041493 | CEMENTEK | Teknimed, S.A. | 2004-08-19 | 76 | 0 |
| K040669 | CERAFORM BONE VOID FILLER | Teknimed, S.A. | 2004-05-03 | 49 | 0 |
| K031826 | TRIHA + | Teknimed, S.A. | 2003-11-28 | 168 | 1 |
| K032685 | CEMSTOP CEMENT RESTRICTOR | Teknimed, S.A. | 2003-11-26 | 89 | 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