Last synced on 18 April 2025 at 11:05 pm

Humerus & Ulna System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213108
510(k) Type
Traditional
Applicant
Auxein Medical Private Limited
Country
India
FDA Decision
Substantially Equivalent
Decision Date
11/4/2022
Days to Decision
406 days
Submission Type
Summary

Humerus & Ulna System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213108
510(k) Type
Traditional
Applicant
Auxein Medical Private Limited
Country
India
FDA Decision
Substantially Equivalent
Decision Date
11/4/2022
Days to Decision
406 days
Submission Type
Summary