K123783

Substantially Equivalent

ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM AND CAPITOL IMPLANTS

Applicant: Globus Medical, Inc.
Product code: KWP
Advisory panel: Orthopedic
Date received: 2012-12-10
Decision date: 2013-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Audubon, PA, US

Adverse events under product code KWP

product code KWP

Death: 7
Injury: 1,539
Malfunction: 1,519
Total: 3,065

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.