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K-wires

Model WIRE-0.7/100 · Trimed, INC. · DI 00842188129759

NDL — Pin, Fixation, Smooth, Metallic · Class II · 21 CFR 888.3040

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.

12232021-10: 0 reports for this device; peer average 3/device10
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2021-1003
This device (reports/month)Average device in NDL (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K243943 — cites (transitively): K050681 (d1), K093676 (d1), K161616 (d1), K012945 (d2), K021556 (d2), K021932 (d2), K050636 (d2), K080943 (d2), K090949 (d2), K112583 (d2), K962011 (d2), K963172 (d2), K963192 (d2), K000682 (d3), K000684 (d3), K023879 (d3), K100776 (d3), K061808 (d4), K063049 (d4), K090063 (d4), K090675 (d4)

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Trimed, INC.

  • Warning Letter 2016-06-30 TriMed Inc.
  • Warning Letter 2016-06-30 TriMed Inc.
  • VAI 2024-06-03 TriMed Inc. · 2 citations
  • VAI 2024-06-03 TriMed Inc. · 2 citations
  • NAI 2019-08-14 TriMed Inc. · 0 citations
  • NAI 2019-08-14 TriMed Inc. · 0 citations
  • VAI 2017-11-17 TriMed Inc. · 6 citations
  • VAI 2017-11-17 TriMed Inc. · 6 citations
  • VAI 2017-01-12 TriMed Inc. · 11 citations
  • VAI 2017-01-12 TriMed Inc. · 11 citations
  • OAI 2016-03-18 TriMed Inc. · 13 citations
  • OAI 2016-03-18 TriMed Inc. · 13 citations
  • VAI 2012-01-25 TriMed Inc. · 5 citations
  • VAI 2012-01-25 TriMed Inc. · 5 citations