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510(k) K254107

Refobacin Bone Cement R (110034355) by Biomet France — Product Code LOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2026
Date Received
December 19, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bone Cement
Device Class
Class II
Regulation Number
888.3027
Review Panel
OR
Submission Type

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