Last synced on 14 November 2025 at 11:06 pm

IR Type Implant System

Page Type
Cleared 510(K)
510(k) Number
K171185
510(k) Type
Traditional
Applicant
Biotem Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
12/1/2017
Days to Decision
221 days
Submission Type
Summary

IR Type Implant System

Page Type
Cleared 510(K)
510(k) Number
K171185
510(k) Type
Traditional
Applicant
Biotem Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
12/1/2017
Days to Decision
221 days
Submission Type
Summary