Cleared Special

LITe Plate System

K150449 · Stryker Corp. · Orthopedic
Mar 2015
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K150449 is an FDA 510(k) clearance for the LITe Plate System, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by Stryker Corp. (Allendale, US). The FDA issued a Cleared decision on March 20, 2015, 28 days after receiving the submission on February 20, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K150449 FDA.gov
FDA Decision Cleared SESE
Date Received February 20, 2015
Decision Date March 20, 2015
Days to Decision 28 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWQ — Appliance, Fixation, Spinal Intervertebral Body
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3060

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