Atlas FDA

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

Sweden & Martina S.P.A. — Predicate Candidate Screening

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

267 daysmedian FDA review time
825 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K222640Sweden & Martina Surgical TraysSweden & Martina S.P.A.2023-05-262670
K182084Sweden & Martina Surgical Tray (Model ZSHORTY-INT)Sweden & Martina S.P.A.2020-11-048250
K180365PRAMA White Implant SystemsSweden & Martina S.P.A.2019-07-085110
K161989PREMIUM Implant Systems SHELTA Implant SystemsSweden & Martina S.P.A.2018-02-015620
K172560PREMIUM ONE Implant SystemsSweden & Martina S.P.A.2017-12-211180
K162028PREMIUM - SHELTA Prosthetic ComponentsSweden & Martina S.P.A.2017-03-242450
K162004PREMIUM Implant Systems SHELTA Implant SystemsSweden & Martina S.P.A.2016-12-051380
K142242PREMIUM, SHELTA Implant SystemsSweden & Martina S.P.A.2015-02-021730

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