Skip to content
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

    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
    2022-11-04NAINo action indicatedChoice Spine LLC0
    2022-11-04NAINo action indicatedChoice Spine LLC0
    2017-08-10NAINo action indicatedChoice Spine LLC0
    2017-08-10NAINo action indicatedChoice Spine LLC0
    2015-09-25NAINo action indicatedChoice Spine LLC0
    2015-09-25NAINo action indicatedChoice Spine LLC0
    2012-11-06VAIVoluntary action indicatedChoice Spine LLC4
    2012-11-06VAIVoluntary action indicatedChoice Spine LLC4
    Similar devices
    Select up to two to place side-by-side with this device.