Last synced on 18 April 2025 at 11:05 pm

AR_N Type Implant System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K171297
510(k) Type
Traditional
Applicant
Biotem Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
1/31/2018
Days to Decision
274 days
Submission Type
Summary

AR_N Type Implant System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K171297
510(k) Type
Traditional
Applicant
Biotem Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
1/31/2018
Days to Decision
274 days
Submission Type
Summary