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4.5mm Drill Bit

Model FC-D-45 · Surgentec, LLC · DI 00858406007495

MRW — System, Facet Screw Spinal Device

UDILibrary device dossier · generated 2026-09-13 · 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

K211855 — cites (transitively): K132126 (d1), K163374 (d1), K092568 (d2), K120340 (d2), K131417 (d2), K052043 (d3), K100154 (d3), K003928 (d3), K021705 (d3), K953076 (d3), K012773 (d4), K071420 (d4) — cited as predicate by K232468, K232605, K240086, K243265, K243865, K251714, K261209

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

Manufacturer compliance record — Surgentec, LLC

  • NAI 2022-12-14 SurGenTec, LLC · 0 citations
  • NAI 2022-12-14 SurGenTec, LLC · 0 citations
  • VAI 2019-04-18 SurGenTec, LLC · 3 citations
  • VAI 2019-04-18 SurGenTec, LLC · 3 citations