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510(k) K053528

SHORT CITATION FEMORAL STEM by Stryker Orthopaedics — Product Code MEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2006
Date Received
December 19, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type

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