Cleared Traditional

K994239 - ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM

K994239 is an FDA 510(k) clearance for ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM, manufactured by Medtronic Sofamor Danek, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K994239 · Medtronic Sofamor Danek, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
186d
Days
Class 2
Risk

K994239 is an FDA 510(k) clearance for the ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek, Inc. (Memphis, US). The FDA issued a Cleared decision on June 19, 2000 after a review of 186 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Sofamor Danek, Inc. devices

FDA 510(k) Submission Details - K994239

510(k) Number K994239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1999
Decision Date June 19, 2000
Days to Decision 186 days
Submission Type Traditional
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
64d slower than avg
Panel avg: 122d · This submission: 186d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 586
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K994239.
SYNTHES CERVIFIX SYSTEM
K001864 · Synthes Spine · Jul 2000
MODIFICATION TO CENTAUR SPINAL SYSTEM
K001844 · Howmedica Osteonics Corp. · Jul 2000
EBI ANTERIOR CERVICAL PLATE SYSTEM
K001794 · Ebi, L.P. · Jul 2000
WINDOW CERVICAL DYNAMIC PLATE SYSTEM
K993066 · Advanced Spine Technology, Inc. · Jun 2000
XIA SPINE SYSTEM
K001272 · Howmedica Osteonics Corp. · May 2000
DELTALOC ANTERIOR CERVICAL PLATE SYSTEM
K993513 · Alphatec Mfg., Inc. · Apr 2000