Home / 510(k) Clearances / K221728

510(k) K221728

Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior Cervical Plating (ACP) System, Reflex™ Hybrid ACP System, UniVise™ Spinous Process Fixation Plate by Stryker Corporation — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2022
Date Received
June 14, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

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