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510(k) K200011

E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS by Microport Orthopedics, Inc. — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 2021
Date Received
January 2, 2020
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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