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510(k) K221809

DePuy Synthes 3.5mm Intrapelvic Acetabular System by DePuy Synthes — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2022
Date Received
June 22, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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