Cleared Special

CD HORIZON SPINAL SYSTEM

K993810 · Danek Medical, Inc. · Orthopedic
Feb 2000
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K993810 is an FDA 510(k) clearance for the CD HORIZON SPINAL SYSTEM, a Orthosis, Spondylolisthesis Spinal Fixation (Class II — Special Controls, product code MNH), submitted by Danek Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on February 3, 2000, 85 days after receiving the submission on November 10, 1999. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K993810 FDA.gov
FDA Decision Cleared SESE
Date Received November 10, 1999
Decision Date February 03, 2000
Days to Decision 85 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MNH — Orthosis, Spondylolisthesis Spinal Fixation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3070