Cleared Traditional

RADIOPAQUE BONE CEMENT

K043518 · Cardinalhealth · Orthopedic
May 2005
Decision
142d
Days
Class 2
Risk

About This 510(k) Submission

K043518 is an FDA 510(k) clearance for the RADIOPAQUE BONE CEMENT, a Cement, Bone, Vertebroplasty (Class II — Special Controls, product code NDN), submitted by Cardinalhealth (Mcgaw Park, US). The FDA issued a Cleared decision on May 11, 2005, 142 days after receiving the submission on December 20, 2004. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number K043518 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2004
Decision Date May 11, 2005
Days to Decision 142 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code NDN — Cement, Bone, Vertebroplasty
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3027

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