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)
Description
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 by Stryker Corporation, an FDA 510(k) cleared neurology device.
Regulatory Information
FDA Database
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Predicate lineage for K212194
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. 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) cites 5 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212397 | StealthStation S8 Cranial v2.0 | Medtronic Navigation | 2021 |
| K162309 | StealthStation S8 System Platforms and StealthStation Crani... | Medtronic Navigation, Inc. | 2017 |
| K162929 | Stryker Navigation System with CranialMap software applicat... | Stryker Corporation | 2017 |
| K143241 | MDT Navigable Brain Biopsy Cannula | Izi Medical Products, LLC | 2015 |
| K141833 | STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PAT... | Medtronic Navigation, Inc. | 2015 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233542 | Ortho Guidance Precision Knee Software; Ortho Guidance Expr... | Stryker Leibinger GmbH & Co KG | 2024 |
| K223280 | Disposible Nitrile Gloves | Holik Asia Group Co.,Ltd | 2023 |
Trace the full predicate network for K212194
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.