Stryker Corporation
FDA 510(k) & PMA Approved Devices — 43 products
Total Devices43
Categories24
Latest FDA decision2023-08-18
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K232157 | Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control | GCJ | 2023-08-18 | View |
| 510(k) | K212194 | 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 | HAW | 2023-02-16 | View |
| 510(k) | K223770 | Sonopet 1Q 3 7cm 1Q Large | LFL | 2023-02-16 | View |
| 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 | KWQ | 2022-10-19 | View |
| 510(k) | K221074 | OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device | GEI | 2022-09-16 | View |
| 510(k) | K221098 | Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit | PGW | 2022-07-12 | View |
| 510(k) | K213824 | Sonopet iQ Ultrasonic Aspirator System | LFL | 2022-02-03 | View |
| 510(k) | K212055 | Connected OR Hub with Device and Voice Control | GCJ | 2021-12-16 | View |
| 510(k) | K210377 | Stryker iBur hubs and cutting accessories | HBE | 2021-06-30 | View |
| 510(k) | K202964 | iBed Wireless with iBed Mobile | FNL | 2021-06-18 | View |
| 510(k) | K211490 | Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000 | ERL | 2021-06-09 | View |
| 510(k) | K202393 | SpineJack Expansion Kit | NDN | 2020-10-20 | View |
| 510(k) | K202609 | Instrument Clamps Electromagnetic | PGW | 2020-10-09 | View |
| 510(k) | K201585 | Monterey AL Interbody System | OVD | 2020-08-10 | View |
| 510(k) | K200613 | Tritanium® X TL Expandable Curved Posterior Lumbar Cage | MAX | 2020-04-15 | View |
| 510(k) | K192818 | Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System | PML | 2020-03-31 | View |
| 510(k) | K200493 | Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover | FXY | 2020-03-21 | View |
| 510(k) | K191049 | Stryker MIS and Footed Attachments | HBE | 2019-06-18 | View |
| 510(k) | K190070 | Sonopet iQ Ultrasonic Aspirator System | LFL | 2019-04-11 | View |
| 510(k) | K183196 | Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker | OLO | 2019-02-14 | View |
No matching devices.
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