Cleared Special

K080191 - EAGLE PLUS MICRO ANTERIOR CERVICAL PLAT...

K080191 is the FDA 510(k) clearance for EAGLE PLUS MICRO ANTERIOR CERVICAL PLAT... by Depuy Spine, Inc.. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Special 510(k) pathway after a 68-day FDA review.

K080191 · Depuy Spine, Inc. · Orthopedic device
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Apr 2008
Decision
68d
Days
Class 2
Risk

K080191 is an FDA 510(k) clearance for the EAGLE PLUS MICRO ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Depuy Spine, Inc. (Raynham, US). The FDA issued a Cleared decision on April 2, 2008 after a review of 68 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 Depuy Spine, Inc. devices

Submission Details

510(k) Number K080191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2008
Decision Date April 02, 2008
Days to Decision 68 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
54d faster than avg
Panel avg: 122d · This submission: 68d
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 373
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K080191.
VIP ANTERIOR CERVICAL PLATE SYSTEM
K081391 · Globus Medical, Inc. · Jul 2008
THOR ANTERIOR PLATING SYSTEM
K080773 · Stryker Spine · Jun 2008
MODIFICATON TO: PYRAMID +4 ANTERIOR LUMBAR PLATE SYSTEM
K080429 · Medtronic Sofamor Danek USA, Inc. · Apr 2008
CAYMAN BUTTRESS PLATE SYSTEM
K080302 · K2m, Inc. · Mar 2008
THOR ANTERIOR PLATING SYSTEM
K073437 · Stryker Spine · Feb 2008
NUVASIVE HELIX MINI ACP SYSTEM
K073275 · Nuvasive, Inc. · Jan 2008