Medtech S.A: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Medtech S.A” (first 2009, latest 2020), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 160 days. Since 2017 the median was 155 days, against 103 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Zimmer Biomet, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 212 |
| 2016 | 1 | 214 |
| 2017 | 0 | — |
| 2018 | 1 | 226 |
| 2019 | 3 | 155 |
| 2020 | 1 | 88 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Medtech S.A took a median 155 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 103 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | 5 | 5 |
| OLO | Orthopedic Stereotaxic Instrument | 3 | 3 |
Review panels
- Neurology (5)
- Orthopedic (3)
Most recent Medtech S.A 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K200511 | ROSA ONE Brain application | HAW | 2020-05-29 | 88 |
| K192173 | ROSA ONE Spine application | OLO | 2019-10-29 | 78 |
| K182848 | ROSA ONE Spine application | OLO | 2019-03-22 | 164 |
| K182417 | ROSA ONE Brain Application | HAW | 2019-02-07 | 155 |
| K172444 | ROSA BRAIN (v3.0.0.5) | HAW | 2018-03-28 | 226 |
| K151511 | ROSA Spine | OLO | 2016-01-04 | 214 |
| K151359 | ROSA Brain | HAW | 2015-12-18 | 212 |
| K092239 | ROSA SURGICAL DEVICE, MODEL ROSA 1.1 | HAW | 2009-11-17 | 117 |
Recalls
openFDA lists no recalls under a recalling firm named Medtech S.A.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Medtech Products, Inc. (14 510(k)s)
- Medtech Intl., Inc. (6 510(k)s)
- Medtech Industries, Inc. (4 510(k)s)
- Medtech S.A.S (3 510(k)s)
- Medtech Instruments (2 510(k)s)
- Medtech , Ltd. (1 510(k)s)
- Medtech Systems, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medtech S.A?
FDA lists 8 510(k) clearances under the applicant name “Medtech S.A” (first 2009, latest 2020), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Medtech S.A?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medtech S.A is 160 days. Since 2017: 155 days, versus 103 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Medtech S.A?
The most frequent FDA product codes under this applicant name are HAW (Neurological Stereotaxic Instrument, 5); OLO (Orthopedic Stereotaxic Instrument, 3).
Next steps
- See all 8 Medtech S.A clearances with predicates and recalls
- Run predicate analysis for product code HAW, Medtech S.A's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.