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510(k) K200007

PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar by Microport Orthopedics, Inc. — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 2020
Date Received
January 2, 2020
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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