FDA applicant

Osteomed Implantes, Ltda

Rio Claro - Sp, BR3 decisions2015–20160 recalls

FDA records 3 decisions for Osteomed Implantes, Ltda (Rio Claro - Sp, BR) from 2015 to 2016: 3 510(k) clearances. Most are in product codes KWQ (Appliance, Fixation, Spinal Intervertebral Body) and MNI (Orthosis, Spinal Pedicle Fixation). Its devices cite 21 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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 Osteomed Implantes, Ltda’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2015high 2 (2015) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Osteomed Implantes, Ltda by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Osteomed”

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

Osteomed LP 73 Osteomed Indústria E Comércio DE Implantes Ltda 1

Osteomed Implantes, Ltda

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 “Osteomed”