HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments— 510(k) K222270

Substantially Equivalent

Globus Medical, Inc.

FDA 510(k) clearance K222270 for HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments, Substantially Equivalent on 2022-10-21. Applicant: Globus Medical, Inc..

Clearance details

Applicant: Globus Medical, Inc.
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2022-07-29
Decision date: 2022-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Audubon, PA, US

Download summary PDF View on FDA.gov ↗

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.