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Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)

Page Type
Cleared 510(K)
510(k) Number
K172116
510(k) Type
Traditional
Applicant
Stryker Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/25/2018
Days to Decision
196 days
Submission Type
Summary

Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)

Page Type
Cleared 510(K)
510(k) Number
K172116
510(k) Type
Traditional
Applicant
Stryker Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/25/2018
Days to Decision
196 days
Submission Type
Summary