Cleared Special

DEVEX MESH SYSTEM

K023835 · Depuyacromed · Orthopedic
Jan 2003
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K023835 is an FDA 510(k) clearance for the DEVEX MESH SYSTEM, a Spinal Vertebral Body Replacement Device (Class II — Special Controls, product code MQP), submitted by Depuyacromed (Raynham, US). The FDA issued a Cleared decision on January 29, 2003, 72 days after receiving the submission on November 18, 2002. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K023835 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 2002
Decision Date January 29, 2003
Days to Decision 72 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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