Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran Anterior Cervical Plating (ACP) System, Reflex Hybrid ACP System, UniVise Spinous Process Fixation Plate— 510(k) K221728

Substantially Equivalent

Stryker Corporation

FDA 510(k) clearance K221728 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, Substantially Equivalent on 2022-10-19. Applicant: Stryker Corporation.

Clearance details

Applicant: Stryker Corporation
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2022-06-14
Decision date: 2022-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allendale, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.