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510(k) K171249

Entrada™ hip stem by Ortho Development Corporation — Product Code MEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 2017
Date Received
April 28, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type

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