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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
  • 510(k)K152568Substantially equivalent (SESE) · 2016-02-11clearance family

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
2024-12-12NAINo action indicatedStryker Spine0
2021-09-13NAINo action indicatedStryker Spine0
2021-07-27NAINo action indicatedK2M, Inc.0
2016-11-16VAIVoluntary action indicatedK2M, Inc.2
2016-02-10NAINo action indicatedStryker Spine0
2015-07-06NAINo action indicatedK2M, Inc.0
2014-02-12NAINo action indicatedK2M, Inc.0
2012-01-12NAINo action indicatedStryker Spine0
2011-09-29VAIVoluntary action indicatedStryker Spine2
2011-01-18VAIVoluntary action indicatedK2M, Inc.2
2010-08-20NAINo action indicatedStryker Spine0
2010-03-17VAIVoluntary action indicatedStryker Spine2
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