Cleared Special

K112206 - CARDIFF ANTERIOR CERVICAL PLATE SYSTEM

K112206 is the FDA 510(k) clearance for CARDIFF ANTERIOR CERVICAL PLATE SYSTEM by Seaspine, Inc.. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Special 510(k) pathway after a 177-day FDA review.

K112206 · Seaspine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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Jan 2012
Decision
177d
Days
Class 2
Risk

K112206 is an FDA 510(k) clearance for the CARDIFF ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Seaspine, Inc. (Vista, US). The FDA issued a Cleared decision on January 25, 2012 after a review of 177 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Seaspine, Inc. devices

Submission Details

510(k) Number K112206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2011
Decision Date January 25, 2012
Days to Decision 177 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
55d slower than avg
Panel avg: 122d · This submission: 177d
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 448
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K112206.
UNIFY DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM
K121049 · Globus Medical, Inc. · Jun 2012
PIONEER LATERAL PLATE SYSTEM
K120724 · Pioneer Surgical Technology, Inc. · May 2012
PLYMOUTH THORACOLUMBAR PLATE SYSTEM
K120092 · Globus Medical, Inc. · Apr 2012
LEXUS ANTERIOR CERVICAL PLATE SYSTEM
K113509 · L & K Biomed Co., Ltd. · Jan 2012
K2M, PYRENEES CERVICAL PLATE SYSTEM
K113329 · K2m, Inc. · Jan 2012
GENESYS SPINE ANTERIOR CERVICAL PLATE SYSTEM
K111132 · Genesys Spine · Dec 2011