Cleared Traditional

K032368 - SONOMA ANTERIOR CERVICAL PLATE SYSTEM

K032368 is an FDA 510(k) clearance for SONOMA ANTERIOR CERVICAL PLATE SYSTEM, manufactured by Seaspine. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K032368 · Seaspine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
69d
Days
Class 2
Risk

K032368 is an FDA 510(k) clearance for the SONOMA ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Seaspine (San Diego, US). The FDA issued a Cleared decision on October 9, 2003 after a review of 69 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 devices

FDA 510(k) Submission Details - K032368

510(k) Number K032368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2003
Decision Date October 09, 2003
Days to Decision 69 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 122d · This submission: 69d
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 538
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K032368.
EAGLE ANTERIOR CERVIAL PLATE SYSTEM
K040197 · Depuyacromed · Apr 2004
SYNTHES VENTROFIX MIS SYSTEM
K031100 · Synthes (Usa) · Mar 2004
SYNTHES ANTERIOR CERVICAL COMPRESSION SYSTEM
K033844 · Synthes (Usa) · Feb 2004
CYCLONE ANTERIOR CERVICAL PLATE SYSTEM
K031214 · Encore Medical, L.P. · Sep 2003
SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEM
K031855 · Spinal Concepts, Inc. · Sep 2003
CD HORIZON SPINAL SYSTEM
K032265 · Medtronic Sofamor Danek · Aug 2003