Cleared Special

C-TEK C-TRUN ANTERIOR CERVICAL PLATE SYSTEM

K042798 · Interpore Cross Intl. · Orthopedic
Nov 2004
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K042798 is an FDA 510(k) clearance for the C-TEK C-TRUN 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 November 4, 2004, 27 days after receiving the submission on October 8, 2004. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K042798 FDA.gov
FDA Decision Cleared SESE
Date Received October 08, 2004
Decision Date November 04, 2004
Days to Decision 27 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

Similar Devices — KWQ Appliance, Fixation, Spinal Intervertebral Body

All 661
ANTERIS Thoracolumbar Plate System
K260015 · SpineCraft · Mar 2026
PathLoc Lumbar Plate System
K251940 · L & K Biomed Co., Ltd. · Mar 2026
Aster
K254182 · Osteonic Co., Ltd. · Feb 2026
Lumbar Spine Truss System - Plating Solution (LSTS-PS)
K253201 · 4Web, Inc. · Feb 2026
aprevo? cervical plating system
K252611 · Carlsmed, Inc. · Dec 2025
Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)
K251965 · Alphatec Spine, Inc. · Aug 2025