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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

    K081396

    Cited as predicate by: K120530, K130572, K131097, K153509, K200265, K222211

    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
    2021-05-12VAIVoluntary action indicatedImplant Direct Sybron Manufacturing LLC1
    2019-12-02OAIOfficial action indicatedImplant Direct Sybron Manufacturing LLC5
    2015-04-21NAINo action indicatedImplant Direct Sybron Manufacturing LLC0
    2014-04-03NAINo action indicatedImplant Direct Sybron Manufacturing LLC0
    2012-02-10NAINo action indicatedImplant Direct Sybron Manufacturing LLC0
    2011-08-16NAINo action indicatedImplant Direct Sybron Manufacturing LLC0
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