FDA applicant

Neoortho Produtos Ortopedicos S/A

San Diego, CA6 decisions2010–20220 recalls

FDA records 6 decisions for Neoortho Produtos Ortopedicos S/A (San Diego, CA) from 2010 to 2022: 6 510(k) clearances. Most are in product codes HSB (Rod, Fixation, Intramedullary And Accessories) and HRS (Plate, Fixation, Bone). Its devices cite 37 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Neoortho Produtos Ortopédicos S/A”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Neoortho Produtos Ortopedicos S/A’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2010high 2 (2014) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Neoortho Produtos Ortopedicos S/A by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Neoortho Produtos Ortopedicos S/A’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Neoortho”

FDA records each applicant name separately; these may or may not be the same firm.

Neoortho Productos Orthopedicos S/A 2

Neoortho Produtos Ortopedicos S/A

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Neoortho”