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510(k) K191056

Conformity stem, cemented by United Orthopedic Corporation — Product Code JDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 2020
Date Received
April 19, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device Class
Class II
Regulation Number
888.3350
Review Panel
OR
Submission Type

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