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510(k) K031474

SC TOTAL HIP SYSTEM by Orthopedic Alliance, LLC — Product Code JDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2003
Date Received
May 9, 2003
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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