Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

Bun-Yo-Matic™ Lapidus Clamp System

Model P30-100-5310 · Paragon 28, Inc. · DI 00889795129413

FZK — Chair, Surgical, Non-Electrical · Class I · 21 CFR 878.4950

UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

No dated reports to chart.

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Paragon 28, Inc.

  • OAI 2025-04-24 Paragon 28, Inc. · 2 citations
  • OAI 2025-04-24 Paragon 28, Inc. · 2 citations
  • NAI 2023-07-13 Paragon 28, Inc. · 0 citations
  • NAI 2023-07-13 Paragon 28, Inc. · 0 citations
  • NAI 2022-08-25 Paragon 28, Inc. · 0 citations