Last synced on 4 February 2023 at 10:33 pm

Ortho System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K171634
510(k) Type
Special
Applicant
3Shape A/S
Country
Denmark
FDA Decision
Substantially Equivalent
Decision Date
1/17/2018
Days to Decision
229 days
Submission Type
Summary

Ortho System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K171634
510(k) Type
Special
Applicant
3Shape A/S
Country
Denmark
FDA Decision
Substantially Equivalent
Decision Date
1/17/2018
Days to Decision
229 days
Submission Type
Summary