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Unnamed device

Model 176202008 · DEPUY SPINE, LLC · DI 10705034036502

EZX — Mesh, Surgical, Metal · Class II · 21 CFR 878.3300

UDILibrary device dossier · generated 2026-09-06 · 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.

01112019-04: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 1/device2019-11: 0 reports for this device; peer average 1/device2020-04: 0 reports for this device; peer average 1/device2021-10: 0 reports for this device; peer average 1/device2021-11: 0 reports for this device; peer average 1/device041011041011
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0401
2019-1001
2019-1101
2020-0401
2021-1001
2021-1101
This device (reports/month)Average device in EZX (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K173787 — cites (transitively): K001340 (d1), K003043 (d1), K020522 (d1), K030249 (d1), K031635 (d1), K073649 (d1), K080568 (d1), K081917 (d1), K101923 (d1), K103488 (d1), K110694 (d1), K120517 (d1), K120966 (d1), K140759 (d1), K151352 (d1), K151773 (d1), K162327 (d1), K900138 (d1), K990148 (d1), P960025 (d1), K052746 (d2), K091088 (d2), K023835 (d2), K030833 (d2), K082128 (d2), K110454 (d2), K123027 (d2), K143163 (d2), K113348 (d2), K122896 (d2), K151472 (d2), K071795 (d3), K072970 (d3), K090899 (d3), K082732 (d3), K083661 (d3), K093704 (d3), K093864 (d3), K100865 (d3), K101051 (d3), K120869 (d3), K133328 (d3), K141217 (d3), K141665 (d3), K141896 (d3), K090166 (d4), K073470 (d4), K080758 (d4), K082014 (d4), K093242 (d4), K080699 (d4), K090816 (d4), K120918 (d4), K123045 (d4), K123231 (d4), K130820 (d4), K131082 (d4), K132601 (d4), K133455 (d4), K140319 (d4), K140659 (d4), K080537 (d5), K023570 (d5), K062933 (d5), K072791 (d5), K073291 (d5), K082310 (d5), K091278 (d5), K092193 (d5), K100042 (d5), K130548 (d5), K043206 (d5), K133623 (d5), K110632 (d5), K122967 (d5), K043479 (d6), P950002 (d6), P950019 (d6), P970015 (d6), K071724 (d6), K073348 (d6), K092901 (d6), K082262 (d7) — cited as predicate by K192214

K900138 — cited as predicate by K173787

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