Cleared Special

C-TEK C-THRU ANTERIOR CERVICAL PLATE SYSTEM

K041794 · Interpore Cross Intl. · Orthopedic
Jul 2004
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K041794 is an FDA 510(k) clearance for the C-TEK C-THRU ANTERIOR CERVICAL PLATE SYSTEM, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by Interpore Cross Intl. (Irvine, US). The FDA issued a Cleared decision on July 19, 2004, 17 days after receiving the submission on July 2, 2004. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K041794 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 2004
Decision Date July 19, 2004
Days to Decision 17 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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