510(k) Report

FDA applicant

BAAT Medical Products B.V.

Hengelo, NL6 decisions2020–20260 recalls

FDA records 6 decisions for BAAT Medical Products B.V. (Hengelo, NL) from 2020 to 2026: 6 510(k) clearances. Most are in product codes MBI (Fastener, Fixation, Nondegradable, Soft Tissue) and HSB (Rod, Fixation, Intramedullary And Accessories). Since 2016 its 510(k)s took a median of 104 days from receipt to decision, against 86 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 1 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 BAAT Medical Products B.V.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2020: 12021: 12023: 12026 (partial year): 3
2020high 3 (2026) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — BAAT Medical Products B.V. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MBIFastener, Fixation, Nondegradable, Soft Tissue2decisions
  • HSBRod, Fixation, Intramedullary And Accessories1decision
  • PGMGrowing Rod System1decision
  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar1decision
  • JDODevice, Fixation, Proximal Femoral, Implant1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 104 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 86 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K220966SinefixBAAT Medical Products B.V. · 20231cites it

What has FDA decided for it lately?

  • K262184Gannet®BAAT Medical Products B.V. · 2026
  • K254176SinefixBAAT Medical Products B.V. · 2026
  • K251961SDS Growing RodBAAT Medical Products B.V. · 2026
  • K220966SinefixBAAT Medical Products B.V. · 2023
  • K211474Kleiner KG2 SystemBAAT Medical Products B.V. · 2021
  • K201830ANSER Clavicle PinBAAT Medical Products B.V. · 2020

All 6 as BAAT Medical Products B.V. →