Cleared Special

K082273 - UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM

K082273 is the FDA 510(k) clearance for UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM by Depuy Spine, Inc.. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Special 510(k) pathway after a 30-day FDA review.

K082273 · Depuy Spine, Inc. · Orthopedic device
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Sep 2008
Decision
30d
Days
Class 2
Risk

K082273 is an FDA 510(k) clearance for the UNIPLATE 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 September 10, 2008 after a review of 30 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 K082273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2008
Decision Date September 10, 2008
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
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 K082273.
THORACOLUMBAR, LUMBAR AND SACRAL PLATES AND 6.0 AND 7.0 MM BONE SCREWS
K081380 · K2m, Inc. · Nov 2008
BIOMET ANTERIOR LUMBAR PLATE
K082187 · Ebi, L.P. · Nov 2008
NUVASIVE LATERAL PLATE SYSTEM
K082070 · Nuvasive, Inc. · Sep 2008
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
K081038 · Medtronic Sofamor Danek · Aug 2008
SPINAL ELEMENTS BUTTRESS PLATE SYSTEM
K081418 · Spinal Elements, Inc. · Jul 2008
VIP ANTERIOR CERVICAL PLATE SYSTEM
K081391 · Globus Medical, Inc. · Jul 2008