Cleared Traditional

K242361 - OZARK Cervical Plate System (FDA 510(k) Clearance)

Also includes:

PYRENEES® Cervical Plate System EVEREST® Spinal System MESA® Spinal System MESA® Small Stature Spinal System CASPIAN® Spinal System DENALI® Spinal System DENALI® MI Spinal System YUKON OCT Spinal System Xia® 3 Spinal System K2M Patient Specific CASCADIA™ Interbody System CAYMAN® Plate System CAYMAN® Plate System-MI

K242361 · Stryker Spine · Orthopedic device

Nov 2024

Decision

90d

Days

Class 2

Risk

K242361 is an FDA 510(k) clearance for the OZARK Cervical Plate System. This device is classified as a Appliance, Fixation, Spinal Intervertebral Body (Class II - Special Controls, product code KWQ).

Submitted by Stryker Spine (Allendale, US). The FDA issued a Cleared decision on November 7, 2024, 90 days after receiving the submission on August 9, 2024.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number	K242361 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 09, 2024
Decision Date	November 07, 2024
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF