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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: K141135, K141665, K141896, K143595, K151214, K153105, K153627, K170962

    K140659

    Cited as predicate by: K141896, K150994

    Cited as predicate by: K240830, K241375, K253876

    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
    2024-05-06VAIVoluntary action indicatedNuVasive Specialized Orthopedics, Inc.12
    2024-01-18NAINo action indicatedNuvasive PR, Inc.0
    2019-12-09NAINo action indicatedNuvasive PR, Inc.0
    2019-07-29NAINo action indicatedNuVasive, Inc0
    2017-05-31NAINo action indicatedNuvasive PR, Inc.0
    2017-05-26VAIVoluntary action indicatedNuVasive Inc2
    2017-05-26VAIVoluntary action indicatedNuVasive Inc2
    2017-05-04VAIVoluntary action indicatedNuVasive, Inc3
    2016-10-26VAIVoluntary action indicatedNuvasive Inc2
    2014-11-19NAINo action indicatedNuVasive Inc0
    2014-11-19NAINo action indicatedNuVasive Inc0
    2014-08-27NAINo action indicatedNuvasive Inc4
    2014-04-01NAINo action indicatedNuvasive PR, Inc.0
    2014-02-20NAINo action indicatedNuVasive Specialized Orthopedics, Inc.0
    2014-02-05NAINo action indicatedNuVasive Inc0
    2014-02-05NAINo action indicatedNuVasive Inc0
    2013-03-12WLWarning LetterNuVasive Inc—
    2013-03-12WLWarning LetterNuVasive Inc—
    2012-11-02OAIOfficial action indicatedNuVasive Inc0
    2012-11-02OAIOfficial action indicatedNuVasive Inc0
    2012-02-10NAINo action indicatedNuVasive Inc0
    2012-02-10NAINo action indicatedNuVasive Inc0
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