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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
510(k) Number K201519
Device Name PROFEMUR® GLADIATOR® Cemented Classic Stem
Applicant
Microport Orthopedics, Inc.
5677 Airline Rd.
Arlington,  TN  38002
Applicant Contact Kristen Russell
Correspondent
Microport Orthopedics, Inc.
5677 Airline Rd.
Arlington,  TN  38002
Correspondent Contact Allen Mamaril
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Codes
KWL   KWY   LZO  
Date Received06/08/2020
Decision Date 12/10/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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