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CLARIANCE

11 clearances · 2 inspections · 1 recalls · aggregated across 2 source records

Scorecard
Events per device across the 3,149-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.

MAUDE reports per device

0

0 in the last 12 months

Higher volume than 83% of companies with 10+ devices

Recalls per device

0

0 in the last 12 months

Higher volume than 97% of companies with 10+ devices

These are reporting-volume percentiles, not safety rankings — MAUDE counts have no denominator of devices in use, and recall attribution follows resolved links. A high percentile means more reports per registered device than peers, which can reflect market size, device criticality, or reporting practice as much as anything else.

Devices
3,149 device records · ordered by linked event volume.
BrandModelProduct codesPrimary DILinked events
Erisma®-LP13911009MNH MNI NKB037007806272715
Idys™- TLIF TiVac41532909-SMAX037007806286434
Erisma®-LP18911039MNH MNI NKB037007806251543
Idys™- ALIF24430014-SOVD037007806271272
ERISMA® LP_NAVIGATED INSTRUMENTS48710003OLO037007806382221
Elegance® Anterior Cervical Plate53430353KWQ037007806446361
Elegance® Anterior Cervical Plate53430338KWQ037007806445821
Elegance® Anterior Cervical Plate53430232KWQ037007806445371
Elegance® Anterior Cervical Plate53430112KWQ037007806443911
Elegance® Anterior Cervical Plate53430344KWQ037007806446051
Elegance® Anterior Cervical Plate53430362KWQ037007806446671
Elegance® Anterior Cervical Plate53430236KWQ037007806445511
Elegance® Anterior Cervical Plate53430356KWQ037007806446431
Elegance® Anterior Cervical Plate53430234KWQ037007806445441
Elegance® Anterior Cervical Plate53430114KWQ037007806444141
Elegance® Anterior Cervical Plate53430113KWQ037007806444071
Elegance® Anterior Cervical Plate53430116KWQ037007806444381
Elegance® Anterior Cervical Plate53430111KWQ037007806443841
Elegance® Anterior Cervical Plate53430228KWQ037007806445131
Elegance® Anterior Cervical Plate53430224KWQ037007806444901
Elegance® Anterior Cervical Plate53430120KWQ037007806444521
Elegance® Anterior Cervical Plate53430108KWQ037007806443531
Elegance® Anterior Cervical Plate53430230KWQ037007806445201
Elegance® Anterior Cervical Plate53430347KWQ037007806446121
Elegance® Anterior Cervical Plate53430350KWQ037007806446291
Elegance® Anterior Cervical Plate53430240KWQ037007806445751
Erisma®-LP18912026MNH MNI NKB037007806251781
Erisma®-LP18911040MNH MNI NKB037007806252391
Erisma®-LP18156550MNH MNI NKB037007806179511
Erisma®-LP13017540MNH MNI NKB037007806151171
Showing 1–30 of 3,149Next →
Facilities
Registered establishments with their latest FDA inspection outcome.

No registered facilities linked.