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

Appliance, Fixation, Spinal Intervertebral Body

Stryker Corporation

The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Aviator® Anterior Cervical Plating (acp) System, Lite® Plate System, Dynatran™ Anterior Cervical Plating (acp) System, Reflex™ Hybrid Acp System, Univise™ Spinous Process Fixation Plate.

Pre-market Notification Details

• Device ID: K221728
• 510k Number: K221728
• Device Name: Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior Cervical Plating (ACP) System, Reflex™ Hybrid ACP System, UniVise™ Spinous Process Fixation Plate
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: Stryker Corporation 2 Pearl Court Allendale, NJ 07401
• Contact: Katie McNeil
• Correspondent: Katie McNeil; Stryker Corporation 2 Pearl Court Allendale, NJ 07401
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-06-14
• Decision Date: 2022-10-19