Neoortho Produtos Ortopedicos S/A: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Neoortho Produtos Ortopedicos S/A” (first 2010, latest 2017), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 147 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 | 1 | 95 |
| 2013 | 0 | — |
| 2014 | 2 | 204 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 257 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 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 Neoortho Produtos Ortopedicos S/A took a median 257 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 107 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 1 | 1 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 | 1 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| JEY | Plate, Bone | 1 | 1 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 | 1 |
Review panels
- Orthopedic (4)
- Dental (1)
Most recent Neoortho Produtos Ortopedicos S/A 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K162874 | Cannulated Screws Neoortho | HWC | 2017-06-27 | 257 |
| K141103 | INTRAMEDULLARY NAIL AND SCREWS-NEONAIL | HSB | 2014-09-23 | 147 |
| K132852 | PEEK CAGE FOR THE VERTEBRAL SPINE | MAX | 2014-05-29 | 260 |
| K113733 | SMALL AND LARGE FRAGMENTS OSTEOSYNTHESIS SYSTEM NEOFIX | HRS | 2012-03-23 | 95 |
| K102641 | MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE | JEY | 2010-12-20 | 98 |
Recalls
openFDA lists no recalls under a recalling firm named Neoortho Produtos Ortopedicos 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.
- Neoortho Productos Orthopedicos S/A (2 510(k)s)
- Neoortho Produtos Ortopédicos S/A (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Neoortho Produtos Ortopedicos S/A?
FDA lists 5 510(k) clearances under the applicant name “Neoortho Produtos Ortopedicos S/A” (first 2010, latest 2017), across 5 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 Neoortho Produtos Ortopedicos S/A?
The median time from FDA receipt to decision across 510(k)s cleared under the name Neoortho Produtos Ortopedicos S/A is 147 days.
Which FDA product codes appear under Neoortho Produtos Ortopedicos S/A?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 1); HSB (Rod, Fixation, Intramedullary And Accessories, 1); HWC (Screw, Fixation, Bone, 1).
Next steps
- See all 5 Neoortho Produtos Ortopedicos S/A clearances with predicates and recalls
- Run predicate analysis for product code HRS, Neoortho Produtos Ortopedicos 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.