510(k) Report

FDA applicant

Medical Design, LLC

Sioux Falls, SD3 decisions2002–20120 recalls

FDA records 3 decisions for Medical Design, LLC (Sioux Falls, SD) from 2002 to 2012: 3 510(k) clearances. Most are in product codes HBG (Drills, Burrs, Trephines & Accessories (Manual)) and KWQ (Appliance, Fixation, Spinal Intervertebral Body). 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 Medical Design, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2012

2012: 2
2007high 2 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medical Design, LLC 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?

  • HBGDrills, Burrs, Trephines & Accessories (Manual)1decision
  • KWQAppliance, Fixation, Spinal Intervertebral Body1decision
  • HWCScrew, Fixation, Bone1decision

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 6 times; 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.

  • K121148Samba Screw, 9MM Dia., 25MM Long, Sambia Screw, 9MM Dia., 30MM Long, Samba Screw 9MM Dia., 35MM Long, Samba…Medical Design, LLC · 20124cite it
  • K022712Hand Drill, Model 11-9901-7Medical Design, LLC · 20021cites it
  • K122497Asfora Anterior Cervical Plate System, One Level, 14MM Asfora Anterior Cervical Plate System, One Level, 16MMMedical Design, LLC · 20121cites it

What has FDA decided for it lately?

  • K122497Asfora Anterior Cervical Plate System, One Level, 14MM Asfora Anterior Cervical Plate System, One Level, 16MMMedical Design, LLC · 2012
  • K121148Samba Screw, 9MM Dia., 25MM Long, Sambia Screw, 9MM Dia., 30MM Long, Samba Screw 9MM Dia., 35MM Long, Samba…Medical Design, LLC · 2012
  • K022712Hand Drill, Model 11-9901-7Medical Design, LLC · 2002

All 3 as Medical Design, LLC →