Cleared Traditional

K083338 - CARDIFF ANTERIOR CERVICAL PLATE SYSTEM

K083338 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 Traditional 510(k) pathway after a 82-day FDA review.

K083338 · Seaspine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
82d
Days
Class 2
Risk

K083338 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 February 2, 2009 after a review of 82 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Seaspine, Inc. devices

Submission Details

510(k) Number K083338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2008
Decision Date February 02, 2009
Days to Decision 82 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
40d faster than avg
Panel avg: 122d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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
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