Cleared Special

K041794 - C-TEK C-THRU ANTERIOR CERVICAL PLATE SYSTEM

K041794 is an FDA 510(k) clearance for C-TEK C-THRU ANTERIOR CERVICAL PLATE SYSTEM, manufactured by Interpore Cross Intl.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Special 510(k) pathway after a 17-day FDA review.

K041794 · Interpore Cross Intl. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
17d
Days
Class 2
Risk

K041794 is an FDA 510(k) clearance for the C-TEK C-THRU ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Interpore Cross Intl. (Irvine, US). The FDA issued a Cleared decision on July 19, 2004 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Interpore Cross Intl. devices

FDA 510(k) Submission Details - K041794

510(k) Number K041794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 122d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

KWQ Device Classification - Class 2, Special Controls

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 623
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K041794.
NUVASIVE ANTERIOR CERVICAL PLATE SYSTEM
K041447 · Nuvasive, Inc. · Aug 2004
ANTERIOR COMPACT SYSTEM
K041469 · X-Spine Systems · Jul 2004
MACROPORE HYDROSORB SPINE SYSTEM
K041105 · Macropore Biosurgery, Inc. · Jul 2004
CD HORIZON SPINAL SYSTEM
K041460 · Medtronic Sofamor Danek USA, Inc. · Jul 2004
ASSURE ANTERIOR CERVICAL PLATE SYSTEM
K040721 · Globus Medical, Inc. · Jun 2004
SWIFT ANTERIOR CERVICAL PLATE SYSTEM
K040655 · Depuy Spine, Inc. · Jun 2004