Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medtech S.A — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
164 daysmedian FDA review time
226 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K200511 | ROSA ONE Brain application | Medtech S.A | 2020-05-29 | 88 | 0 |
| K192173 | ROSA ONE Spine application | Medtech S.A | 2019-10-29 | 78 | 0 |
| K182848 | ROSA ONE Spine application | Medtech S.A | 2019-03-22 | 164 | 0 |
| K182417 | ROSA ONE Brain Application | Medtech S.A | 2019-02-07 | 155 | 0 |
| K172444 | ROSA BRAIN (v3.0.0.5) | Medtech S.A | 2018-03-28 | 226 | 1 |
| K151511 | ROSA Spine | Medtech S.A | 2016-01-04 | 214 | 1 |
| K151359 | ROSA Brain | Medtech S.A | 2015-12-18 | 212 | 2 |
| K092239 | ROSA SURGICAL DEVICE, MODEL ROSA 1.1 | Medtech S.A | 2009-11-17 | 117 | 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