ANTHEM Fracture System— 510(k) K163361

Substantially Equivalent

Globus Medical, Inc.

FDA 510(k) clearance K163361 for ANTHEM Fracture System, Substantially Equivalent on 2017-04-07. Applicant: Globus Medical, Inc..

Clearance details

Applicant: Globus Medical, Inc.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2016-11-30
Decision date: 2017-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Audubon, PA, US

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Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.