Cleared Special

DEPUY ACROMED VBR SYSTEM

K030833 · Depuyacromed · Orthopedic
Apr 2003
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K030833 is an FDA 510(k) clearance for the DEPUY ACROMED VBR 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 April 10, 2003, 24 days after receiving the submission on March 17, 2003. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K030833 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 2003
Decision Date April 10, 2003
Days to Decision 24 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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