Last synced on 14 November 2025 at 11:06 pm

US SA Implant System

Page Type
Cleared 510(K)
510(k) Number
K161103
510(k) Type
Traditional
Applicant
OSSTEM IMPLANT CO.,LTD.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
2/2/2017
Days to Decision
289 days
Submission Type
Summary

US SA Implant System

Page Type
Cleared 510(K)
510(k) Number
K161103
510(k) Type
Traditional
Applicant
OSSTEM IMPLANT CO.,LTD.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
2/2/2017
Days to Decision
289 days
Submission Type
Summary