Cleared Special

MODIFICATION TO GEO STRUCTURE

K020048 · Interpore Cross Intl. · Orthopedic
Feb 2002
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K020048 is an FDA 510(k) clearance for the MODIFICATION TO GEO STRUCTURE, a Spinal Vertebral Body Replacement Device (Class II — Special Controls, product code MQP), submitted by Interpore Cross Intl. (Irvine, US). The FDA issued a Cleared decision on February 6, 2002, 30 days after receiving the submission on January 7, 2002. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K020048 FDA.gov
FDA Decision Cleared SESE
Date Received January 07, 2002
Decision Date February 06, 2002
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MQP — Spinal Vertebral Body Replacement Device
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3060

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