510(k) Report

FDA applicant

Glw Medical, Inc.

Englewood Cliff, NJ2 decisions2020–20220 recalls

FDA records 2 decisions for Glw Medical, Inc. (Englewood Cliff, NJ) from 2020 to 2022: 2 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HWC (Screw, Fixation, Bone). 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 Glw Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2020: 12022: 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Glw Medical, Inc. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Glw Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • HRSPlate, Fixation, Bone1decision
  • 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 3 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.

  • K200291CREED™ Cannulated ScrewsGlw Medical, Inc. · 20202cite it
  • K213005Apollo Ankle Fracture Plating SystemGlw Medical, Inc. · 20221cites it

What has FDA decided for it lately?

  • K213005Apollo Ankle Fracture Plating SystemGlw Medical, Inc. · 2022
  • K200291CREED™ Cannulated ScrewsGlw Medical, Inc. · 2020

All 2 as Glw Medical, Inc. →