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510(k) K231526

CORAIL Cemented Femoral Stem by Depuy Ireland UC — Product Code KWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2023
Date Received
May 26, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Device Class
Class II
Regulation Number
888.3390
Review Panel
OR
Submission Type

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