New Deal, S.A.: FDA filings under this applicant name
FDA lists 28 510(k) clearances under the applicant name “New Deal, S.A.” (first 1999, latest 2007), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 72 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | 10 | 10 |
| HRS | Plate, Fixation, Bone | 9 | 9 |
| JDR | Staple, Fixation, Bone | 4 | 4 |
| HTY | Pin, Fixation, Smooth | 2 | 2 |
| JDW | Pin, Fixation, Threaded | 2 | 2 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 | 1 |
Review panels
- Orthopedic (28)
Most recent New Deal, S.A. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K070241 | MODIFICATION TO LAPIDUS PLATE | HRS | 2007-02-08 | 14 |
| K070160 | MODIFICATION TO TTC PLATES | HRS | 2007-02-08 | 22 |
| K063820 | LISFRANC PLATE | HRS | 2007-02-08 | 44 |
| K060474 | LISFRANC PLATE | HRS | 2006-08-03 | 161 |
| K061765 | KALIX II IMPLANT | HWC | 2006-07-18 | 26 |
| K061594 | LARGE UNI-CLIP STAPLE | JDR | 2006-07-03 | 25 |
| K060476 | LAPIDUS PLATE | HRS | 2006-05-17 | 83 |
| K060473 | TTC PLATE | HRS | 2006-05-17 | 83 |
| K053093 | KALIX II IMPLANT, MODEL 141 0XX WITH XX | HWC | 2005-12-07 | 34 |
| K052152 | B-BOP PLATE | HRS | 2005-09-13 | 36 |
18 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named New Deal, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under New Deal, S.A.?
FDA lists 28 510(k) clearances under the applicant name “New Deal, S.A.” (first 1999, latest 2007), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by New Deal, S.A.?
The median time from FDA receipt to decision across 510(k)s cleared under the name New Deal, S.A. is 72 days.
Which FDA product codes appear under New Deal, S.A.?
The most frequent FDA product codes under this applicant name are HWC (Screw, Fixation, Bone, 10); HRS (Plate, Fixation, Bone, 9); JDR (Staple, Fixation, Bone, 4).
Next steps
- See all 28 New Deal, S.A. clearances with predicates and recalls
- Run predicate analysis for product code HWC, New Deal, 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.