Cleared Special

MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM

K982875 · Danek Medical, Inc. · Orthopedic
Jan 1999
Decision
158d
Days
Class 2
Risk

About This 510(k) Submission

K982875 is an FDA 510(k) clearance for the MODIFICATION TO 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 January 19, 1999, 158 days after receiving the submission on August 14, 1998. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K982875 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 1998
Decision Date January 19, 1999
Days to Decision 158 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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