Cleared Special

INTERPORE CROSS CEMENT RESTRICTOR

K032095 · Interpore Cross Intl. · Orthopedic
Aug 2003
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K032095 is an FDA 510(k) clearance for the INTERPORE CROSS CEMENT RESTRICTOR, a Prosthesis, Hip, Cement Restrictor (Class II — Special Controls, product code JDK), submitted by Interpore Cross Intl. (Irvine, US). The FDA issued a Cleared decision on August 8, 2003, 31 days after receiving the submission on July 8, 2003. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number K032095 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 2003
Decision Date August 08, 2003
Days to Decision 31 days
Submission Type Special
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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