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510(k) K210402

Curiteva Sacroiliac Joint Fusion System by Curiteva, Inc. — Product Code OUR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2021
Date Received
February 10, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sacroiliac Joint Fixation
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

sacroiliac joint fusion

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