Cleared Special

ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

K993855 · Danek Medical, Inc. · Orthopedic
Dec 1999
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K993855 is an FDA 510(k) clearance for the ATLANTIS ANTERIOR CERVICAL PLATE 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 December 15, 1999, 30 days after receiving the submission on November 15, 1999. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K993855 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 1999
Decision Date December 15, 1999
Days to Decision 30 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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