Stryker Corporation
FDA 510(k) & PMA Approved Devices — 43 products
Total Devices43
Categories24
Latest Approval2023-08-18
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 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 |
| 510(k) | K181752 | Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) | HRX | 2018-12-21 | View |
| 510(k) | K180327 | Stryker iVAS 13g Bone Biopsy Kit | KNW | 2018-02-26 | View |
| 510(k) | K172116 | Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) | HRX | 2018-01-25 | View |
| 510(k) | K172034 | 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 | OLO | 2017-10-18 | View |
| 510(k) | K172724 | XIA® 4.5 Spinal System, Power Adaptor Instrument Accessory | NKB | 2017-10-10 | View |
| 510(k) | K172558 | iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy Kit | KNW | 2017-10-05 | View |
| 510(k) | K171840 | Stryker Consolidated Operating Room Equipment (CORE) 2 Console | ERL | 2017-09-15 | View |
| 510(k) | K171807 | ES2 Neuromonitoring Accessory Instruments | PDQ | 2017-07-18 | View |
| 510(k) | K170242 | MultiGen 2 RF Generator System | GXD | 2017-05-25 | View |
| 510(k) | K170496 | Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory | NKB | 2017-05-16 | View |
| 510(k) | K162937 | Stryker OrthoMap Versatile Hip System | OLO | 2017-02-23 | View |
| 510(k) | K162929 | Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker | HAW | 2017-02-22 | View |
| 510(k) | K161514 | Precision Thin Reciprocating Blade, 0.010in. | EQJ | 2017-01-17 | View |
| 510(k) | K162062 | AVAmax Vertebral Balloon, AVAflex Vertebral Balloon | HRX | 2016-11-01 | View |
| PMA | P960053 | Prosthesis, finger, constrained, metal/polymer | KWG | 2016-08-09 | View |
| 510(k) | K160715 | AccuLIF TL and PL Cage | MAX | 2016-07-08 | View |
| 510(k) | K160978 | LITe BIO Delivery System | FMF | 2016-07-08 | View |
| 510(k) | K160050 | SERFAS 90-S Electrosurgical Probe | GEI | 2016-05-03 | View |
| 510(k) | K153407 | Stryker Neptune 3 Waste Management System | JCX | 2016-04-25 | View |
| 510(k) | K160693 | Neptune E-SEP Smoke Evacuation Pencil | GEI | 2016-04-13 | View |
| 510(k) | K151932 | Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing | HRX | 2016-03-31 | View |
| 510(k) | K153679 | Stryker Neptune E-SEP Smoke Evacuation Pencil | GEI | 2016-01-22 | View |
| 510(k) | K151726 | AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK Spacer, AVS Navigator PEEK Spacer, AVS ARIA PEEK Spacer | MAX | 2016-01-20 | View |
No matching devices.