Cleared Traditional

SIMPLEX P BONE CEMENT

K062553 · Stryker Orthopaedics · Orthopedic
Jan 2007
Decision
131d
Days
Class 2
Risk

About This 510(k) Submission

K062553 is an FDA 510(k) clearance for the SIMPLEX P BONE CEMENT, a Bone Cement (Class II — Special Controls, product code LOD), submitted by Stryker Orthopaedics (Malwah, US). The FDA issued a Cleared decision on January 8, 2007, 131 days after receiving the submission on August 30, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number K062553 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 2006
Decision Date January 08, 2007
Days to Decision 131 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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