Last synced on 25 November 2022 at 11:04 pm

Ortho System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161884
510(k) Type
Traditional
Applicant
3Shape A/S
Country
Denmark
FDA Decision
Substantially Equivalent
Decision Date
4/19/2017
Days to Decision
282 days
Submission Type
Statement

Ortho System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161884
510(k) Type
Traditional
Applicant
3Shape A/S
Country
Denmark
FDA Decision
Substantially Equivalent
Decision Date
4/19/2017
Days to Decision
282 days
Submission Type
Statement