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DISCOVERY

Model 175704050 · DEPUY SPINE, LLC · DI 10705034034713

MRW — System, Facet Screw Spinal Device

UDILibrary device dossier · generated 2026-09-11 · 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.

11222023-09: 0 reports for this device; peer average 2/device2024-03: 0 reports for this device; peer average 2/device0903
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2023-0902
2024-0302
This device (reports/month)Average device in MRW (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K012773 — cited as predicate by K100154, K101284, K101762, K102438, K113011, K121850, K173198, K192281, K232605

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

Manufacturer compliance record — DEPUY SPINE, LLC

  • NAI 2019-04-18 DePuy Spine, Inc. · 0 citations
  • NAI 2019-04-18 DePuy Spine, Inc. · 0 citations
  • NAI 2017-06-16 DePuy Spine, Inc. · 0 citations
  • NAI 2017-06-16 DePuy Spine, Inc. · 0 citations
  • NAI 2012-06-11 DePuy Spine, Inc. · 0 citations
  • NAI 2012-06-11 DePuy Spine, Inc. · 0 citations
  • NAI 2012-03-06 Depuy Spine Inc · 0 citations
  • VAI 2012-02-10 DePuy Spine, Inc. · 2 citations
  • VAI 2012-02-10 DePuy Spine, Inc. · 2 citations