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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Talladium España, SL · Predicate Candidate Screening

10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

197 daysmedian FDA review time
652 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K243732Multi-Unit DAS SystemTalladium España, SL2026-01-294210
K243425Guided DAS Surgical KitTalladium España, SL2025-07-222600
K243530Dynamic TiBaseTalladium España, SL2025-05-301970
K241170Dynamic TiBase; TRI ScrewsTalladium España, SL2024-10-211780
K231559Multi-Unit DAS SystemTalladium España, SL2023-11-171710
K232151Dynamic TiBaseTalladium España, SL2023-10-17900
K221966Dynamic TiBaseTalladium Espana, SL2022-09-15720
K212108Dynamic TiBaseTalladium España, SL2021-09-24800
K1620213.0 Dynamic TiBaseTalladium Espana, SL2018-05-046520
K090081TALLADIUM INTERNATIONAL IMPLANTOLOGY ABUTMENTSTalladium Espana, SL2010-06-225260

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