Cleared Special

SPECTRUM GV Bone Cement

K250760 · Osteoremedies, LLC · Orthopedic
Apr 2025
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K250760 is an FDA 510(k) clearance for the SPECTRUM GV Bone Cement, a Bone Cement (Class II — Special Controls, product code LOD), submitted by Osteoremedies, LLC (Memphis, US). The FDA issued a Cleared decision on April 2, 2025, 20 days after receiving the submission on March 13, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number K250760 FDA.gov
FDA Decision Cleared SESE
Date Received March 13, 2025
Decision Date April 02, 2025
Days to Decision 20 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code LOD — Bone Cement
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3027

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