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510(k) K172251

UTS Stem by United Orthopedic Corporation — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2017
Date Received
July 26, 2017
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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