Last synced on 12 April 2024 at 11:04 pm

Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K221087
510(k) Type
Traditional
Applicant
Medtronic Navigation, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/10/2022
Days to Decision
58 days
Submission Type
Summary

Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K221087
510(k) Type
Traditional
Applicant
Medtronic Navigation, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/10/2022
Days to Decision
58 days
Submission Type
Summary