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510(k) K183312

Conformity Stem by United Orthopedic Corporation — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2019
Date Received
November 29, 2018
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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