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510(k) K152439

U2 Bipolar Implant and 22mm Femoral Head by United Orthopedic Corporation — Product Code KWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 2016
Date Received
August 27, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Device Class
Class II
Regulation Number
888.3390
Review Panel
OR
Submission Type

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