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510(k) K142675

CI../..X liner for NOVAE Dual Mobility Acetabular Cup by Serf — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2015
Date Received
September 19, 2014
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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