Cleared Traditional

SURGICAL DYNAMICS MESH CAGE SYSTEM

K003709 · United States Surgical, A Division of Tyco Healthc · Orthopedic
Jul 2001
Decision
229d
Days
Class 2
Risk

About This 510(k) Submission

K003709 is an FDA 510(k) clearance for the SURGICAL DYNAMICS MESH CAGE SYSTEM, a Spinal Vertebral Body Replacement Device (Class II — Special Controls, product code MQP), submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on July 18, 2001, 229 days after receiving the submission on December 1, 2000. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K003709 FDA.gov
FDA Decision Cleared SESE
Date Received December 01, 2000
Decision Date July 18, 2001
Days to Decision 229 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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