SPECTRUM® GV Bone Cement— 510(k) K231556

Substantially Equivalent

Osteoremedies, LLC

FDA 510(k) clearance K231556 for SPECTRUM® GV Bone Cement, Substantially Equivalent on 2023-12-20. Applicant: Osteoremedies, LLC.

Clearance details

Applicant: Osteoremedies, LLC
Product code: Code LOD
Advisory panel: Orthopedic
Date received: 2023-05-30
Decision date: 2023-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LOD

product code LOD

Death: 44
Injury: 3,004
Malfunction: 895
Other: 4
Total: 3,947

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.