Cleared Traditional

KMI CEMENT RESTRICTOR IMPLANT

K061465 · Kinetikos Medical, Inc. · Orthopedic
Oct 2006
Decision
132d
Days
Class 2
Risk

About This 510(k) Submission

K061465 is an FDA 510(k) clearance for the KMI CEMENT RESTRICTOR IMPLANT, a Prosthesis, Hip, Cement Restrictor (Class II — Special Controls, product code JDK), submitted by Kinetikos Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on October 5, 2006, 132 days after receiving the submission on May 26, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number K061465 FDA.gov
FDA Decision Cleared SESU
Date Received May 26, 2006
Decision Date October 05, 2006
Days to Decision 132 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDK — Prosthesis, Hip, Cement Restrictor
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3300

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