510(k) Report

FDA applicant

Industrias Medicas Sampedro S.A.S

La Estrella, CO2 decisions2019–20210 recalls

FDA records 2 decisions for Industrias Medicas Sampedro S.A.S (La Estrella, CO) from 2019 to 2021: 2 510(k) clearances. Most are in product codes JEY (Plate, Bone) and HRS (Plate, Fixation, Bone). Its devices cite 2 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, dental panel, where it files most

How often FDA has decided Industrias Medicas Sampedro S.A.S’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2019: 12021: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Industrias Medicas Sampedro S.A.S by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JEYPlate, Bone1decision
  • HRSPlate, Fixation, Bone1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius Plates, AFFINITY –…Industrias Medicas Sampedro S.A.S · 20193cite it
  • K203282TECHFIT Patient-Specific Maxillofacial SystemIndustrias Medicas Sampedro S.A.S · 20211cites it

What has FDA decided for it lately?

  • K203282TECHFIT Patient-Specific Maxillofacial SystemIndustrias Medicas Sampedro S.A.S · 2021
  • K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius Plates, AFFINITY –…Industrias Medicas Sampedro S.A.S · 2019

All 2 as Industrias Medicas Sampedro S.A.S →

Other applicant names beginning “Industrias”

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

Industrias Palex C/O Dma Med-Chem Corp. 5Industrias Tuk, S.A. DE C.V. 3