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StealthStation S8 System Platforms and StealthStation Cranial Software

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K162309
510(k) Type
Traditional
Applicant
MEDTRONIC NAVIGATION, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/31/2017
Days to Decision
226 days
Submission Type
Summary

StealthStation S8 System Platforms and StealthStation Cranial Software

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K162309
510(k) Type
Traditional
Applicant
MEDTRONIC NAVIGATION, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/31/2017
Days to Decision
226 days
Submission Type
Summary