510(k) K063822

MODIFICATION TO HIPSTAR FEMORAL STEM by Stryker Orthopaedics — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2007
Date Received
December 26, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device Class
Class II
Regulation Number
888.3358
Review Panel
OR
Submission Type