Cleared Traditional

Aviator? Anterior Cervical Plating (ACP) System, LITe? Plate System, DynaTran? Anterior Cervical Plating (ACP) System, Reflex? Hybrid ACP System, UniVise? Spinous Process Fixation Plate

K221728 · Stryker Corporation · Orthopedic
Oct 2022
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K221728 is an FDA 510(k) clearance for the Aviator? Anterior Cervical Plating (ACP) System, LITe? Plate System, DynaTran? Anterior Cervical Plating (ACP) System, Reflex? Hybrid ACP System, UniVise? Spinous Process Fixation Plate, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by Stryker Corporation (Allendale, US). The FDA issued a Cleared decision on October 19, 2022, 127 days after receiving the submission on June 14, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K221728 FDA.gov
FDA Decision Cleared SESE
Date Received June 14, 2022
Decision Date October 19, 2022
Days to Decision 127 days
Submission Type Traditional
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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