Cleared Traditional

K103068 - KING COBRA ANTERIOR CERVICAL PLATE

K103068 is an FDA 510(k) clearance for KING COBRA ANTERIOR CERVICAL PLATE, manufactured by Eminent Spine. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K103068 · Eminent Spine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
88d
Days
Class 2
Risk

K103068 is an FDA 510(k) clearance for the KING COBRA ANTERIOR CERVICAL PLATE. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Eminent Spine (Chesterland, US). The FDA issued a Cleared decision on January 14, 2011 after a review of 88 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 Eminent Spine devices

FDA 510(k) Submission Details - K103068

510(k) Number K103068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2010
Decision Date January 14, 2011
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
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 472
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K103068.
MIS ANTERIOR CERVICAL PLATING SYSTEM
K103423 · Life Spine · Jun 2011
NUVASIVE TRAVERSE PLATE SYSTEM
K103750 · Nuvasive, Inc. · Mar 2011
GOLDEN GATE ANTERIOR PLATE SYSTEM
K101353 · Ulrich GmbH & Co. KG · Feb 2011
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
K102820 · Alphatec Spine, Inc. · Nov 2010
SAPPHIRE ANTERIOR CERVICAL PLATE SYSTEM
K101848 · Spinal Elements, Inc. · Oct 2010
LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEM
K102265 · Ldr Spine USA · Sep 2010