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ZYFUSE

Model 147.630S · GLOBUS MEDICAL, INC. · DI 00889095334166

MRW — System, Facet Screw Spinal Device

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.

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

K090952 — cited as predicate by K162825

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

Manufacturer compliance record — GLOBUS MEDICAL, INC.

  • Warning Letter 2024-07-15 Globus Medical, Inc.
  • Warning Letter 2024-07-15 Globus Medical, Inc.
  • Warning Letter 2013-09-26 Globus Medical, Inc.
  • Warning Letter 2013-09-26 Globus Medical, Inc.
  • VAI 2025-10-16 Globus Medical, Inc. · 1 citations
  • VAI 2025-10-16 Globus Medical, Inc. · 1 citations
  • OAI 2025-08-13 Nevro Corporation · 6 citations
  • NAI 2025-03-25 Nuvasive Manufacturing LLC. · 0 citations
  • OAI 2024-03-07 Globus Medical, Inc. · 6 citations
  • OAI 2024-03-07 Globus Medical, Inc. · 6 citations
  • VAI 2023-12-20 Nevro Corporation · 1 citations
  • NAI 2022-07-29 Nevro Medical SRL · 0 citations
  • NAI 2022-04-26 Nevro Corporation · 0 citations
  • NAI 2019-10-23 Globus Medical, Inc. · 0 citations
  • NAI 2019-10-23 Globus Medical, Inc. · 0 citations
  • VAI 2019-09-27 Globus Medical, Inc. · 7 citations
  • VAI 2019-09-27 Globus Medical, Inc. · 7 citations
  • NAI 2019-03-21 Nevro Corporation · 0 citations
  • VAI 2019-02-13 Globus Medical, Inc. · 2 citations
  • VAI 2019-02-13 Globus Medical, Inc. · 2 citations
  • NAI 2018-03-16 Nevro Corporation · 0 citations
  • VAI 2017-11-03 Nevro Corporation · 5 citations
  • NAI 2017-09-25 Globus Medical, Inc. · 0 citations
  • NAI 2017-09-25 Globus Medical, Inc. · 0 citations