Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker— 510(k) K162929
Substantially EquivalentStryker Corporation
FDA 510(k) clearance K162929 for Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker, Substantially Equivalent on 2017-02-22. Applicant: Stryker Corporation. Device class: 2.
Clearance details
- Applicant
- Stryker Corporation
- Product code
- Code HAW
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Freiburg Baden-Wurttemberg, DE
Recent devices under product code HAW
view allMore clearances from Stryker Corporation
view all- K232157 — Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control
- 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
- K223770 — Sonopet 1Q 3 7cm 1Q Large
- 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
- K221074 — OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device
Adverse events under product code HAW
product code HAW- Death
- 52
- Injury
- 1,083
- Malfunction
- 17,300
- Total
- 18,435
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.