510(k) K173951

Legend Acetabular Liners by Ortho Development Corporation — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2018
Date Received
December 27, 2017
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