Last synced on 25 January 2026 at 3:41 am

WINSIX Implant System

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K133733
510(k) Type
Traditional
Applicant
Biosaf IN S.R.L.
Country
Italy
FDA Decision
Substantially Equivalent
Decision Date
1/28/2015
Days to Decision
418 days
Submission Type
Summary

WINSIX Implant System

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K133733
510(k) Type
Traditional
Applicant
Biosaf IN S.R.L.
Country
Italy
FDA Decision
Substantially Equivalent
Decision Date
1/28/2015
Days to Decision
418 days
Submission Type
Summary