510(k) Report

FDA applicant

Baumer, S.A

Mogi Mirim, Sao Paulo, BR4 decisions2000–20010 recalls

FDA records 4 decisions for Baumer, S.A (Mogi Mirim, Sao Paulo, BR) from 2000 to 2001: 4 510(k) clearances. Most are in product codes JDI (Prosthesis, Hip, Semi-Constrained…) and JDS (Nail, Fixation, Bone). 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 Baumer, S.A’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Baumer, S.A since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Baumer, S.A by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented3decisions
  • JDSNail, Fixation, Bone1decision

What has FDA decided for it lately?

  • K011504Baumer Locking NailBaumer, S.A · 2001
  • K003975Baumer Cemented Hip ProsthesisBaumer, S.A · 2001
  • K003976Baumer Muller Hip ProsthesisBaumer, S.A · 2001
  • K001571Baumer Femoral HeadBaumer, S.A · 2000

All 4 as Baumer, S.A →

Other applicant names beginning “Baumer”

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

Baumer Ortopedia, Ltd. 5