K173115

Substantially Equivalent

COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS

Applicant: Globus Medical, Inc.
Product code: ODP
Advisory panel: Orthopedic
Date received: 2017-09-29
Decision date: 2017-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Audubon, PA, US

Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

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.