510(k) Report

FDA applicant

Groupe Lepine

Sarasota, FL2 decisions1999–20000 recalls

FDA records 2 decisions for Groupe Lepine (Sarasota, FL) from 1999 to 2000: 2 510(k) clearances. Most are in product codes JDR (Staple, Fixation, Bone) and HWC (Screw, Fixation, Bone). 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 Groupe Lepine’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Groupe Lepine since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Groupe Lepine 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?

  • JDRStaple, Fixation, Bone1decision
  • HWCScrew, Fixation, Bone1decision

Who builds on its devices?

Later devices cite its devices 2 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.

  • K991962Eis Dynamic Memory Staples SystemGroupe Lepine · 20001cites it
  • K991964Eis Threaded Screw Fracture FixationGroupe Lepine · 19991cites it

What has FDA decided for it lately?

  • K991962Eis Dynamic Memory Staples SystemGroupe Lepine · 2000
  • K991964Eis Threaded Screw Fracture FixationGroupe Lepine · 1999

All 2 as Groupe Lepine →