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ANCHOR FS™ Facet Fixation System
Model PFF0040 · MEDTRONIC SOFAMOR DANEK, INC. · DI 00643169099425
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.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2023-09 | 0 | 2 |
| 2024-03 | 0 | 2 |
Regulatory clearances
- K101765 SESE 2010-10-22 (k number procode)
Manufacturer compliance record — MEDTRONIC SOFAMOR DANEK, INC.
- NAI 2026-02-06 Medtronic Sofamor Danek USA Inc · 0 citations
- NAI 2017-10-26 Medtronic Sofamor Danek USA, Inc · 0 citations
- VAI 2015-11-03 Medtronic Sofamor Danek USA Inc · 0 citations
- VAI 2015-10-23 Medtronic Sofamor Danek USA Inc · 1 citations
- VAI 2014-03-11 Medtronic Sofamor Danek USA Inc · 0 citations
- NAI 2013-07-15 Medtronic Sofamor Danek USA, Inc · 0 citations
- NAI 2013-07-15 Medtronic Sofamor Danek USA Inc · 0 citations
- VAI 2012-06-06 Medtronic Sofamor Danek USA Inc · 0 citations
- NAI 2011-02-23 Medtronic Sofamor Danek Usa Inc · 0 citations
- VAI 2010-08-06 Medtronic Sofamor Danek USA Inc · 0 citations
- VAI 2010-03-04 Medtronic Sofamor Danek USA Inc · 0 citations
- NAI 2010-02-25 Medtronic Sofamor Danek USA Inc · 0 citations