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ION Facet Screw System

Model TI-AE-55-45 · Surgentec, LLC · DI 00858406007990

MRW — System, Facet Screw Spinal Device

UDILibrary device dossier · generated 2026-09-16 · 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

K241416 — cites (transitively): K240086 (d1), K201900 (d2), K211855 (d2), K200431 (d3), K132126 (d3), K163374 (d3), K092568 (d4), K120340 (d4), K131417 (d4), K170675 (d4), K052043 (d5), K100154 (d5), K003928 (d5), K021705 (d5), K953076 (d5), K142611 (d5), K142661 (d5), K161568 (d5), K012773 (d6), K071420 (d6), K130943 (d6), K132699 (d6), K121476 (d6), K141245 (d6), K063091 (d7), K131007 (d7) — cited as predicate by K243265, K251714, K261209

K243265 — cites (transitively): K211855 (d1), K241416 (d1), K132126 (d2), K163374 (d2), K240086 (d2), K092568 (d3), K120340 (d3), K131417 (d3), K201900 (d3), K052043 (d4), K100154 (d4), K003928 (d4), K021705 (d4), K953076 (d4), K200431 (d4), K012773 (d5), K071420 (d5), K170675 (d5), K142611 (d6), K142661 (d6), K161568 (d6), K130943 (d7), K132699 (d7), K121476 (d7), K141245 (d7), K063091 (d8), K131007 (d8) — cited as predicate by K251714, K253604, 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