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510(k) K131022

OVATION 10/12 HIP STEM by Ortho Development Corp. — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2013
Date Received
April 12, 2013
Clearance Type
Traditional
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

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