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510(k) K233724

28mm/38D MDM X3 Insert for MDM Liner by Howmedica Osteonics Corp., Dba Stryker Orthopaedics — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2024
Date Received
November 21, 2023
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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