510(k) K212194 ยท HAW Neurological Stereotaxic Instrument
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
| Applicant | Stryker Corporation, Freiburg, DE |
| Decision | Substantially Equivalent, Feb 16, 2023 |
| Received | Jul 14, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212194
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 29, 2026 | Stryker Leibinger GmbH & Co. KG Precision Pointer Electromagnetic (8000-050-001) Open, Classified |
HAW | None listed |
| Dec 19, 2025 | Howmedica Osteonics Corp. The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) as well as an electronics control unit fo Open, Classified |
HAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.