Last synced on 12 July 2024 at 11:04 pm

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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K212194
510(k) Type
Traditional
Applicant
Stryker Corporation
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
2/16/2023
Days to Decision
582 days
Submission Type
Summary

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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K212194
510(k) Type
Traditional
Applicant
Stryker Corporation
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
2/16/2023
Days to Decision
582 days
Submission Type
Summary