Cleared Traditional

K243369 - Cervical Plating System

K243369 is the FDA 510(k) clearance for Cervical Plating System by Life Spine, Inc.. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K243369 · Life Spine, Inc. · Orthopedic device
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Dec 2024
Decision
42d
Days
Class 2
Risk

K243369 is an FDA 510(k) clearance for the Cervical Plating System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Life Spine, Inc. (Huntley, US). The FDA issued a Cleared decision on December 11, 2024 after a review of 42 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 Life Spine, Inc. devices

Submission Details

510(k) Number K243369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2024
Decision Date December 11, 2024
Days to Decision 42 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
80d faster than avg
Panel avg: 122d · This submission: 42d
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 428
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K243369.
X-PAC® N-GAGE™ Lumbar Plate System
K250602 · Expanding Innovations, Inc. · May 2025
Skyway Anterior Cervical Plate System
K250486 · Kyocera Medical Technologies Inc. (KMTI) · Apr 2025
Elegance® Anterior Cervical plate
K243904 · Clariance · Jan 2025
OZARK Cervical Plate System
K242361 · Stryker Spine · Nov 2024
Skyway Anterior Cervical Plate System
K243015 · Kyocera Medical Technologies, Inc. · Nov 2024
FlexWing Anterior Cervical Plate System
K231251 · Jeil Medical Corporation · Jul 2024