Last synced on 18 April 2025 at 11:05 pm

8plant Implant System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231426
510(k) Type
Traditional
Applicant
Hoowon EDI Co., Ltd
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
5/24/2024
Days to Decision
373 days
Submission Type
Summary

8plant Implant System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231426
510(k) Type
Traditional
Applicant
Hoowon EDI Co., Ltd
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
5/24/2024
Days to Decision
373 days
Submission Type
Summary