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510(k) K141001

ALPINE HIP STEM; ALPINE HA HIP STEM by Ortho Development — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2014
Date Received
April 18, 2014
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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