Stryker Corporation - FDA 510(k) Cleared Devices
Recent clearances: Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control, Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System, Sonopet 1Q 3 7cm 1Q Large
81
Total
81
Cleared
0
Denied
FDA 510(k) Regulatory Record - Stryker Corporation Orthopedic ✕
40 devices
Cleared
Oct 19, 2022
Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System,...
Orthopedic
127d
Cleared
Oct 20, 2020
SpineJack Expansion Kit
Orthopedic
60d
Cleared
Aug 10, 2020
Monterey AL Interbody System
Orthopedic
60d
Cleared
Apr 15, 2020
Tritanium® X TL Expandable Curved Posterior Lumbar Cage
Orthopedic
37d
Cleared
Mar 31, 2020
Vertaplex HV High Viscosity Radiopaque Bone Cement
Orthopedic
182d
Cleared
Feb 14, 2019
Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy...
Orthopedic
87d
Cleared
Dec 21, 2018
Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS...
Orthopedic
172d
Cleared
Jan 25, 2018
Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS...
Orthopedic
196d
Cleared
Oct 18, 2017
Stryker Spine Navigation System with SpineMap 3D software application,...
Orthopedic
105d
Cleared
Oct 10, 2017
XIA® 4.5 Spinal System, Power Adaptor Instrument Accessory
Orthopedic
29d
Cleared
May 16, 2017
Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory
Orthopedic
88d
Cleared
Feb 23, 2017
Stryker OrthoMap Versatile Hip System
Orthopedic
126d
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