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510(k) K110290

EXETER HIP STEM by Howmedica Osteonics Corp. — Product Code JDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2011
Date Received
February 1, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device Class
Class II
Regulation Number
888.3350
Review Panel
OR
Submission Type

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