510(k) Report

FDA applicant

Gebr. Brasseler GmbH & Co. KG

Washington, DC2 decisions2007–20130 recalls

FDA records 2 decisions for Gebr. Brasseler GmbH & Co. KG (Washington, DC) from 2007 to 2013: 2 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and EJL (Bur, Dental). Its devices cite 5 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 Gebr. Brasseler GmbH & Co. KG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2007: 12013: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Gebr. Brasseler GmbH & Co. KG by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Gebr. Brasseler GmbH & Co. KG’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

Which product codes does it file in?

  • HWCScrew, Fixation, Bone1decision
  • EJLBur, Dental1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K131264Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and ScrewsGebr. Brasseler GmbH & Co. KG · 20131cites it

What has FDA decided for it lately?

  • K131264Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and ScrewsGebr. Brasseler GmbH & Co. KG · 2013
  • K071352CeradrillGebr. Brasseler GmbH & Co. KG · 2007

All 2 as Gebr. Brasseler GmbH & Co. KG →