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510(k) K161080

Escalade Legend Acetabular Shell by Ortho Development Corporation — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2016
Date Received
April 18, 2016
Clearance Type
Special
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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