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510(k) K153216

Alpine Cemented Hip System by Ortho Development Corporation — Product Code JDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 2016
Date Received
November 5, 2015
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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