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510(k) K152903

REVIVAL(TM) Modular Revision Hip Stem by Corin USA — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2016
Date Received
October 1, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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