Last synced on 14 November 2025 at 11:06 pm

IU Implant System

Page Type
Cleared 510(K)
510(k) Number
K172345
510(k) Type
Traditional
Applicant
Warantec Co.,Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
6/18/2018
Days to Decision
320 days
Submission Type
Summary

IU Implant System

Page Type
Cleared 510(K)
510(k) Number
K172345
510(k) Type
Traditional
Applicant
Warantec Co.,Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
6/18/2018
Days to Decision
320 days
Submission Type
Summary