CONCORD Plus Radiopaque Bone Cement— 510(k) K162618

Substantially Equivalent

Globus Medical, Inc.

FDA 510(k) clearance K162618 for CONCORD Plus Radiopaque Bone Cement, Substantially Equivalent on 2017-01-23. Applicant: Globus Medical, Inc..

Clearance details

Applicant: Globus Medical, Inc.
Product code: Code NDN
Advisory panel: Orthopedic
Date received: 2016-09-20
Decision date: 2017-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Audubon, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NDN

product code NDN

Death: 24
Injury: 407
Malfunction: 1,975
Total: 2,406

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.