Cleared Traditional

SPECTRUM? GV Bone Cement

K231556 · Osteoremedies, LLC · Orthopedic
Dec 2023
Decision
204d
Days
Class 2
Risk

About This 510(k) Submission

K231556 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 December 20, 2023, 204 days after receiving the submission on May 30, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number K231556 FDA.gov
FDA Decision Cleared SESE
Date Received May 30, 2023
Decision Date December 20, 2023
Days to Decision 204 days
Submission Type Traditional
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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