COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS— 510(k) K173115

Substantially Equivalent

Globus Medical, Inc.

FDA 510(k) clearance K173115 for COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS, Substantially Equivalent on 2017-12-20. Applicant: Globus Medical, Inc..

Clearance details

Applicant: Globus Medical, Inc.
Product code: 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

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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.