Cleared Special

MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEM

K990603 · Danek Medical, Inc. · Orthopedic
Mar 1999
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K990603 is an FDA 510(k) clearance for the MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEM, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by Danek Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on March 10, 1999, 15 days after receiving the submission on February 23, 1999. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K990603 FDA.gov
FDA Decision Cleared SESE
Date Received February 23, 1999
Decision Date March 10, 1999
Days to Decision 15 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWQ — Appliance, Fixation, Spinal Intervertebral Body
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3060

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