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FacetFuse®

Model 01-00021-LW5025 · SPINEFRONTIER, INC. · DI 00190361018933

MRW — System, Facet Screw Spinal Device

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.

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

K071420 — cited as predicate by K100154, K102438, K121850, K123932, K143377, K232605

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

Manufacturer compliance record — SPINEFRONTIER, INC.

  • Warning Letter 2012-08-08 SpineFrontier, Inc.
  • VAI 2026-04-02 SpineFrontier, Inc. · 1 citations
  • VAI 2019-01-29 SpineFrontier, Inc. · 0 citations
  • NAI 2013-08-05 SpineFrontier, Inc. · 0 citations
  • OAI 2012-07-11 SpineFrontier, Inc. · 9 citations