Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Neoortho Produtos Ortopédicos S/A · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
244 daysmedian FDA review time
260 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221021 | Femoral Trochanteric Nail System – Neonail | Neoortho Produtos Ortopédicos S/A | 2022-12-06 | 244 | 0 |
| K162874 | Cannulated Screws Neoortho | Neoortho Produtos Ortopedicos S/A | 2017-06-27 | 257 | 0 |
| K141103 | INTRAMEDULLARY NAIL AND SCREWS-NEONAIL | Neoortho Produtos Ortopedicos S/A | 2014-09-23 | 147 | 0 |
| K132852 | PEEK CAGE FOR THE VERTEBRAL SPINE | Neoortho Produtos Ortopedicos S/A | 2014-05-29 | 260 | 0 |
| K113733 | SMALL AND LARGE FRAGMENTS OSTEOSYNTHESIS SYSTEM NEOFIX | Neoortho Produtos Ortopedicos S/A | 2012-03-23 | 95 | 0 |
| K102641 | MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE | Neoortho Produtos Ortopedicos S/A | 2010-12-20 | 98 | 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