Medical Device Manufacturer · US , Malwah , NJ

Stryker Corporation

81 submissions · 81 cleared · Since 2010
81
Total
81
Cleared
0
Denied

Stryker Corporation — FDA 510(k) Submissions

Stryker Corporation has submitted 81 FDA 510(k) premarket notifications since 2010, of which 81 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Intervertebral Fusion Device With Bone Graft, Lumbar, Cement, Bone, Vertebroplasty, Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece, Arthroscope, Thoracolumbosacral Pedicle Screw System . Use the specialty filter in the sidebar to narrow results.

81 devices
1–25 of 81
Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control
K232157 · GCJ Laparoscope, General &... · General & Plastic Surgery
Aug 2023 29d
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
K212194 · HAW Neurological Stereotaxic... · Neurology
Feb 2023 582d
Sonopet 1Q 3 7cm 1Q Large
K223770 · LFL Instrument, Ultrasonic... · General & Plastic Surgery
Feb 2023 63d
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 · KWQ Appliance, Fixation,... · Orthopedic
Oct 2022 127d
OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device
K221074 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Sep 2022 157d
Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit
K221098 · PGW Ear, Nose, And Throat... · Ear, Nose, Throat
Jul 2022 89d
Sonopet iQ Ultrasonic Aspirator System
K213824 · LFL Instrument, Ultrasonic... · General & Plastic Surgery
Feb 2022 57d
Connected OR Hub with Device and Voice Control
K212055 · GCJ Laparoscope, General &... · General & Plastic Surgery
Dec 2021 168d
Stryker iBur hubs and cutting accessories
K210377 · HBE Drills, Burrs, Trephines... · Neurology
Jun 2021 141d
iBed Wireless with iBed Mobile
K202964 · FNL Bed, Ac-powered... · General Hospital
Jun 2021 261d
Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000
K211490 · ERL Drill, Surgical, Ent... · Ear, Nose, Throat
Jun 2021 27d
SpineJack Expansion Kit
K202393 · NDN Cement, Bone, Vertebroplasty · Orthopedic
Oct 2020 60d
Instrument Clamps Electromagnetic
K202609 · PGW Ear, Nose, And Throat... · Ear, Nose, Throat
Oct 2020 30d
Monterey AL Interbody System
K201585 · OVD Intervertebral Fusion... · Orthopedic
Aug 2020 60d
Tritanium? X TL Expandable Curved Posterior Lumbar Cage
K200613 · MAX Intervertebral Fusion... · Orthopedic
Apr 2020 37d
Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System
K192818 · PML Bone Cement, Posterior... · Orthopedic
Mar 2020 182d
Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover
K200493 · FXY Hood, Surgical · General Hospital
Mar 2020 22d
Stryker MIS and Footed Attachments
K191049 · HBE Drills, Burrs, Trephines... · Neurology
Jun 2019 60d
Sonopet iQ Ultrasonic Aspirator System
K190070 · LFL Instrument, Ultrasonic... · General & Plastic Surgery
Apr 2019 86d
Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker
K183196 · OLO Orthopedic Stereotaxic... · Orthopedic
Feb 2019 87d
Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)
K181752 · HRX Arthroscope · Orthopedic
Dec 2018 172d
Stryker iVAS 13g Bone Biopsy Kit
K180327 · KNW Instrument, Biopsy · Gastroenterology & Urology
Feb 2018 20d
Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)
K172116 · HRX Arthroscope · Orthopedic
Jan 2018 196d
Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap
K172034 · OLO Orthopedic Stereotaxic... · Orthopedic
Oct 2017 105d
XIA? 4.5 Spinal System, Power Adaptor Instrument Accessory
K172724 · NKB Thoracolumbosacral... · Orthopedic
Oct 2017 29d

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