FDA 510(k)

SPECTRUM® GV Bone Cement

K-Number: K231556 · 2023-12-20

Decision Date2023-12-20

Product CodeLOD

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SPECTRUM® GV Bone Cement is a medical device manufactured by Osteoremedies, LLC. It received FDA 510(k) clearance on 2023-12-20 under approval number K231556. The device is classified under product code LOD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRUM® GV Bone Cement?

SPECTRUM® GV Bone Cement is a medical device that received FDA 510(k) clearance on 2023-12-20. It is manufactured by Osteoremedies, LLC. The 510(k) number is K231556.

When was SPECTRUM® GV Bone Cement approved by the FDA?

SPECTRUM® GV Bone Cement received FDA 510(k) clearance on 2023-12-20, under approval number K231556.

What company makes SPECTRUM® GV Bone Cement?

SPECTRUM® GV Bone Cement is manufactured by Osteoremedies, LLC.

What is the FDA product code for SPECTRUM® GV Bone Cement?

The FDA product code for SPECTRUM® GV Bone Cement is LOD.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.