HEDRON Cervical Spacers (HEDRON C-MIS Spacer)— 510(k) K253876

Substantially Equivalent

Globus Medical, Inc.

FDA 510(k) clearance K253876 for HEDRON Cervical Spacers (HEDRON C-MIS Spacer), Substantially Equivalent on 2025-12-22. Applicant: Globus Medical, Inc..

Clearance details

Applicant: Globus Medical, Inc.
Product code: Code OVE
Advisory panel: Orthopedic
Date received: 2025-12-04
Decision date: 2025-12-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Audubon, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OVE

product code OVE

Injury: 293
Malfunction: 710
Total: 1,003

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.