Newdeal Sas: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Newdeal Sas” (first 2007, latest 2012), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 44 days. 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 Integra LifeSciences, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 466 |
| 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 |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 7 | 7 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 | 1 |
| HTY | Pin, Fixation, Smooth | 1 | 1 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
Review panels
- Orthopedic (10)
Most recent Newdeal Sas 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K103623 | NEWDEAL INTERPHALANGEAL IMPLANT | HTY | 2012-03-20 | 466 |
| K093914 | NEWDEAL COMPRESSION PLATES | HRS | 2011-04-14 | 478 |
| K093781 | MODIFIED: NEWDEAL HALLU PLATES | HRS | 2010-01-22 | 44 |
| K091788 | PANTA NAIL (DIA. 10MM), PANTA NAIL XL | HSB | 2009-07-29 | 42 |
| K083154 | NEWDEAL HALLU LOCK PLATE SYSTEM | HRS | 2009-07-10 | 259 |
| K091609 | NEWDEAL COMPRESSION PLATE | HRS | 2009-06-30 | 27 |
| K073375 | NEWDEAL TIBIAXYS SYSTEM | HRS | 2008-02-21 | 80 |
| K071639 | QWIX POSITIONING SCREW | HWC | 2007-07-09 | 24 |
| K070447 | NEWDEAL COMPRESSION PLATE | HRS | 2007-03-29 | 42 |
| K063831 | BASAL DORSAL PLATES | HRS | 2007-02-07 | 43 |
Recalls
openFDA lists no recalls under a recalling firm named Newdeal Sas.
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.
Parent company SEC filings
INTEGRA LIFESCIENCES HOLDINGS CORP (IART): EDGAR filings, CIK 917520. Caduvo groups Newdeal Sas under Integra LifeSciences; the parent's SEC registrant is entered by hand for the group, not matched by name.
Frequently asked questions
How many FDA 510(k) clearances are listed under Newdeal Sas?
FDA lists 10 510(k) clearances under the applicant name “Newdeal Sas” (first 2007, latest 2012), across 4 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 Newdeal Sas?
The median time from FDA receipt to decision across 510(k)s cleared under the name Newdeal Sas is 44 days.
Which FDA product codes appear under Newdeal Sas?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 7); HSB (Rod, Fixation, Intramedullary And Accessories, 1); HTY (Pin, Fixation, Smooth, 1).
Next steps
- See all 10 Newdeal Sas clearances with predicates and recalls
- Run predicate analysis for product code HRS, Newdeal Sas'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.