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510(k) K222448

UNITY Sacroiliac Joint Fixation System by Dio Medical Corporation — Product Code OUR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 2022
Date Received
August 15, 2022
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

Other clearances by Dio Medical Corporation

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