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Arthrex®

Model AR-1535S · ARTHREX, INC. · DI 00888867306721

KQX — Goniometer, Ac-Powered · Class I · 21 CFR 888.1500

UDILibrary device dossier · generated 2026-09-12 · 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.

01112020-03: 0 reports for this device; peer average 1/device2020-11: 0 reports for this device; peer average 1/device0311
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2020-0301
2020-1101
This device (reports/month)Average device in KQX (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — ARTHREX, INC.

  • VAI 2025-01-13 Arthrex, Inc. · 2 citations
  • VAI 2025-01-13 Arthrex, Inc. · 2 citations
  • VAI 2023-05-05 Arthrex, Inc. · 2 citations
  • VAI 2023-05-05 Arthrex, Inc. · 2 citations
  • VAI 2016-08-25 Arthrex, Inc. · 1 citations
  • VAI 2016-08-25 Arthrex, Inc. · 1 citations
  • NAI 2013-09-27 Arthrex Gmbh · 0 citations
  • NAI 2013-09-27 Arthrex Gmbh · 0 citations
  • NAI 2013-09-25 ARTHREX GMBH · 0 citations
  • NAI 2013-09-25 ARTHREX GMBH · 0 citations