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3P Small-Mini Frag System

Model 01-3100-1019 · ORTHOPEDIATRICS CORP. · DI 00840536800275

GEG — Elevator, Surgical, General & Plastic Surgery · Class I · 21 CFR 878.4800

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.

11222023-04: 0 reports for this device; peer average 2/device2026-04: 0 reports for this device; peer average 2/device0404
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2023-0402
2026-0402
This device (reports/month)Average device in GEG (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — ORTHOPEDIATRICS CORP.

  • VAI 2023-08-18 OrthoPediatrics Corp · 1 citations
  • VAI 2023-08-18 OrthoPediatrics Corp · 1 citations
  • VAI 2017-03-23 OrthoPediatrics Corp · 6 citations
  • VAI 2017-03-23 OrthoPediatrics Corp · 6 citations
  • NAI 2014-06-19 OrthoPediatrics Corp · 0 citations
  • NAI 2014-06-19 OrthoPediatrics Corp · 0 citations
  • VAI 2011-03-11 OrthoPediatrics Corp · 2 citations
  • VAI 2011-03-11 OrthoPediatrics Corp · 2 citations