510(k) Report

FDA applicant

Gm Dos Reis Industria E Comerico Ltda.

Campinas, BR3 decisions2019–20230 recalls

FDA records 3 decisions for Gm Dos Reis Industria E Comerico Ltda. (Campinas, BR) from 2019 to 2023: 3 510(k) clearances. Most are in product codes MBI (Fastener, Fixation, Nondegradable, Soft Tissue) and NKB (Thoracolumbosacral Pedicle Screw System). Since 2016 its 510(k)s took a median of 329 days from receipt to decision, against 84 for FDA’s reviews in the same codes and years. Its devices cite 6 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 Gm Dos Reis Industria E Comerico Ltda.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2019: 22023: 1
2019high 2 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Gm Dos Reis Industria E Comerico Ltda. 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?

  • MBIFastener, Fixation, Nondegradable, Soft Tissue1decision
  • NKBThoracolumbosacral Pedicle Screw System1decision
  • HRSPlate, Fixation, Bone1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 329 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 84 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 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.

  • K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda. · 20194cite it
  • K223114Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGm Dos Reis Industria E Comerico Ltda. · 20231cites it

What has FDA decided for it lately?

  • K223114Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGm Dos Reis Industria E Comerico Ltda. · 2023
  • K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda. · 2019
  • K180626Pedimax II - Pedicular Screw Spinal SystemGm Dos Reis Industria E Comerico Ltda. · 2019

All 3 as Gm Dos Reis Industria E Comerico Ltda. →