Cleared Traditional

VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM

K061155 · Zimmer Trabecular · Orthopedic
Sep 2006
Decision
149d
Days
Class 2
Risk

About This 510(k) Submission

K061155 is an FDA 510(k) clearance for the VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM, a Spinal Vertebral Body Replacement Device (Class II — Special Controls, product code MQP), submitted by Zimmer Trabecular (Allendale, US). The FDA issued a Cleared decision on September 22, 2006, 149 days after receiving the submission on April 26, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K061155 FDA.gov
FDA Decision Cleared SESE
Date Received April 26, 2006
Decision Date September 22, 2006
Days to Decision 149 days
Submission Type Traditional
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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