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primaLOK FF

Model 800-1140-00 · Wenzel Spine, Inc. · DI 00813210021983

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 (1)

InitiatedRecall #ClassStatusReasonLink basis
2011-06-07Z-0008-2012TerminatedTwo of the Implant Driver Assembly tips were reported to break during surgery.k number procode

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

  • K102438 SESE 2010-09-30 (k number procode)

Predicate lineage

K102438 — cites (transitively): K012773 (d1), K071420 (d1), K082795 (d1) — cited as predicate by K110170, K240085

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

Manufacturer compliance record — Wenzel Spine, Inc.

  • NAI 2018-08-29 Wenzel Spine, Inc. · 0 citations
  • NAI 2018-08-29 Wenzel Spine, Inc. · 0 citations
  • VAI 2016-03-11 Wenzel Spine, Inc. · 7 citations
  • VAI 2016-03-11 Wenzel Spine, Inc. · 7 citations
  • NAI 2012-10-15 Wenzel Spine, Inc. · 0 citations
  • NAI 2012-10-15 Wenzel Spine, Inc. · 0 citations