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510(k) K243927

MobileLink Acetabular Cup System - inhouse coatings by Waldemar Link GmbH & Co. KG — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2025
Date Received
December 20, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type

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