Last synced on 25 January 2026 at 3:41 am

SPINAUT-P

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K150915
510(k) Type
Traditional
Applicant
Imedicom Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
3/18/2016
Days to Decision
347 days
Submission Type
Summary

SPINAUT-P

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K150915
510(k) Type
Traditional
Applicant
Imedicom Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
3/18/2016
Days to Decision
347 days
Submission Type
Summary