510(k) Report

FDA applicant

Tecnologia Y Diseno Industrial, S.A DE C.V

South Lyon, MI2 decisions2010–20130 recalls

FDA records 2 decisions for Tecnologia Y Diseno Industrial, S.A DE C.V (South Lyon, MI) from 2010 to 2013: 2 510(k) clearances. Most are in product codes KTT (Appliance, Fixation, Nail/Blade/Plate…) and HWC (Screw, Fixation, Bone). Its devices cite 13 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 Tecnologia Y Diseno Industrial, S.A DE C.V’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2010: 12013: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Tecnologia Y Diseno Industrial, S.A DE C.V by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component1decision
  • HWCScrew, Fixation, Bone1decision

Whose devices does it build on?

Its devices cite 13 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.

  • K101254Newfix Screw, Wire and Pin Fixarion SystemTecnologia Y Diseno Industrial, S.A DE C.V · 20101cites it

What has FDA decided for it lately?

  • K122210Newfix External Fixation SystemTecnologia Y Diseno Industrial, S.A DE C.V · 2013
  • K101254Newfix Screw, Wire and Pin Fixarion SystemTecnologia Y Diseno Industrial, S.A DE C.V · 2010

All 2 as Tecnologia Y Diseno Industrial, S.A DE C.V →