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Adverse-event reports (MAUDE)

Read this first: 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 shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history

No recalls linked.

Regulatory clearances

    Predicate lineage

    Cited as predicate by: K191565, K191581, K192018, K192054

    Cited as predicate by: K191581, K192054, K192502, K210470, K211258

    Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

    Manufacturer compliance record
    DateTypeOutcomeFacilityCitations
    2026-02-06NAINo action indicatedMedtronic Sofamor Danek USA Inc0
    2017-10-26NAINo action indicatedMedtronic Sofamor Danek USA, Inc0
    2015-11-03VAIVoluntary action indicatedMedtronic Sofamor Danek USA Inc0
    2015-10-23VAIVoluntary action indicatedMedtronic Sofamor Danek USA Inc1
    2014-03-11VAIVoluntary action indicatedMedtronic Sofamor Danek USA Inc0
    2013-07-15NAINo action indicatedMedtronic Sofamor Danek USA, Inc0
    2013-07-15NAINo action indicatedMedtronic Sofamor Danek USA Inc0
    2012-06-06VAIVoluntary action indicatedMedtronic Sofamor Danek USA Inc0
    2011-02-23NAINo action indicatedMedtronic Sofamor Danek Usa Inc0
    2010-08-06VAIVoluntary action indicatedMedtronic Sofamor Danek USA Inc0
    2010-03-04VAIVoluntary action indicatedMedtronic Sofamor Danek USA Inc0
    2010-02-25NAINo action indicatedMedtronic Sofamor Danek USA Inc0
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