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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: K212904, K213359

    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
    2026-02-24WLWarning LetterIsoTis OrthoBiologics, Inc.—
    2025-10-17OAIOfficial action indicatedIsoTis OrthoBiologics, Inc.3
    2022-04-22NAINo action indicatedSEASPINE ORTHOPEDICS CORPORATION0
    2022-04-22NAINo action indicatedSEASPINE ORTHOPEDICS CORPORATION0
    2018-08-14NAINo action indicatedSEASPINE ORTHOPEDICS CORPORATION0
    2018-08-14NAINo action indicatedSEASPINE ORTHOPEDICS CORPORATION0
    2015-09-25NAINo action indicatedIsoTis OrthoBiologics, Inc.0
    2012-04-27NAINo action indicatedIsoTis OrthoBiologics, Inc.0
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