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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 664
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K032368.
SYNTHES ANTERIOR CERVICAL COMPRESSION SYSTEM
K033844 · Synthes (Usa) · Feb 2004
VERTELINK KOBRA SPINAL FIXATION SYSTEM
K032102 · Vertelink Corporation · Dec 2003
R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM
K032752 · R&B Surgical Solutions, LLC · Dec 2003
CYCLONE ANTERIOR CERVICAL PLATE SYSTEM
K031214 · Encore Medical, L.P. · Sep 2003
MODIFICATION TO HIGHGATE CURVED ROD SYSTEM
K023983 · Highgate Orthopaedics · Sep 2003
HALM ZIELKE INSTRUMENTATION SYSTEM
K024125 · Micomed Ortho GmbH · Sep 2003
K032368 · SONOMA ANTERIOR CERVICAL PLATE SYSTEM
Download PDF FDA Summary Seaspine