Cleared Traditional

VUSION TS, PS, AND CS PARTIAL VERTEBRAL BODY REPLACEMENTS

K062666 · Ortho Development Corp. · Orthopedic
Jan 2007
Decision
140d
Days
Class 2
Risk

About This 510(k) Submission

K062666 is an FDA 510(k) clearance for the VUSION TS, PS, AND CS PARTIAL VERTEBRAL BODY REPLACEMENTS, a Spinal Vertebral Body Replacement Device (Class II — Special Controls, product code MQP), submitted by Ortho Development Corp. (Draper, US). The FDA issued a Cleared decision on January 25, 2007, 140 days after receiving the submission on September 7, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K062666 FDA.gov
FDA Decision Cleared SESE
Date Received September 07, 2006
Decision Date January 25, 2007
Days to Decision 140 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement

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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