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ALPHALOK Plating System

Model TCS20-25 · VILEX LLC · DI 00841731130976

HWW — Countersink · Class I · 21 CFR 888.4540

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.

01112022-07: 0 reports for this device; peer average 1/device07
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2022-0701
This device (reports/month)Average device in HWW (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — VILEX LLC

  • Warning Letter 2018-01-10 Vilex in Tennessee, Inc.
  • NAI 2018-07-19 Vilex in Tennessee, Inc. · 0 citations
  • OAI 2017-08-25 Vilex in Tennessee, Inc. · 5 citations
  • VAI 2012-11-01 Vilex in Tennessee, Inc. · 7 citations
  • VAI 2010-09-01 Vilex in Tennessee, Inc. · 4 citations