Cleared Special

K030327 - ZEPHIR ANTERIOR CERVICAL SYSTEM

K030327 is the FDA 510(k) clearance for ZEPHIR ANTERIOR CERVICAL SYSTEM by Medtronic Sofamor Danek. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Special 510(k) pathway after a 26-day FDA review.

K030327 · Medtronic Sofamor Danek · Orthopedic device
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Feb 2003
Decision
26d
Days
Class 2
Risk

K030327 is an FDA 510(k) clearance for the ZEPHIR ANTERIOR CERVICAL SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on February 26, 2003 after a review of 26 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 Medtronic Sofamor Danek devices

Submission Details

510(k) Number K030327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2003
Decision Date February 26, 2003
Days to Decision 26 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
96d faster than avg
Panel avg: 122d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 438
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K030327.
BLACKSTONE FUSION ANTERIOR CERVICAL PLATING SYSTEM
K030595 · Blackstone Medical, Inc. · Apr 2003
SYNTHES ANTERIOR CSLP SYSTEM
K030866 · Synthes (Usa) · Apr 2003
BLACKSTONE CLASSIC ANTERIOR CERVICAL PLATE
K022965 · Blackstone Medical, Inc. · Mar 2003
SPINAL CONCEPTS, INC. ANT-CER DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM
K024326 · Spinal Concepts, Inc. · Jan 2003
BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM
K021039 · Depuyacromed · Dec 2002
CERVIVE ANTERIOR CERVICAL PLATING SYSTEM, MODEL NUMBER 157.XXX SERIES CATALOGUE NUMBERS
K022798 · Corin USA · Nov 2002