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2.4mm Distal Radius System

Page Type
Cleared 510(K)
510(k) Number
K211324
510(k) Type
Traditional
Applicant
Auxein Medical Private Limited
Country
India
FDA Decision
Substantially Equivalent
Decision Date
3/14/2022
Days to Decision
318 days
Submission Type
Summary

2.4mm Distal Radius System

Page Type
Cleared 510(K)
510(k) Number
K211324
510(k) Type
Traditional
Applicant
Auxein Medical Private Limited
Country
India
FDA Decision
Substantially Equivalent
Decision Date
3/14/2022
Days to Decision
318 days
Submission Type
Summary