Cleared Special

SURGICAL TITANIUM MESH SYSTEM

K030249 · Depuyacromed · Orthopedic
Feb 2003
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K030249 is an FDA 510(k) clearance for the SURGICAL TITANIUM 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 February 14, 2003, 21 days after receiving the submission on January 24, 2003. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K030249 FDA.gov
FDA Decision Cleared SESE
Date Received January 24, 2003
Decision Date February 14, 2003
Days to Decision 21 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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