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510(k) K103233

MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERT by Howmedica Osteonics Corp. — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 2011
Date Received
November 2, 2010
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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