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510(k) K042973

SOLITUDE UNIPOLAR HEAD by Ortho Development Corp. — Product Code KWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2005
Date Received
October 28, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal
Device Class
Class II
Regulation Number
888.3360
Review Panel
OR
Submission Type

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