Cleared Traditional

ATLAS SPINE VERTEBRAL BODY REPLACEMENT

K063464 · Atlas Spine, Inc. · Orthopedic
Mar 2007
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K063464 is an FDA 510(k) clearance for the ATLAS SPINE VERTEBRAL BODY REPLACEMENT, a Spinal Vertebral Body Replacement Device (Class II — Special Controls, product code MQP), submitted by Atlas Spine, Inc. (Jupiter, US). The FDA issued a Cleared decision on March 9, 2007, 113 days after receiving the submission on November 16, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K063464 FDA.gov
FDA Decision Cleared SESE
Date Received November 16, 2006
Decision Date March 09, 2007
Days to Decision 113 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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