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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, Porous Uncemented
510(k) Number K240046
Device Name Ethylene Oxide Sterilization Supplier Change for MPO Hips
Applicant
Microport Orthopedics
5677 Airline Rd.
Arlington,  TN  38139
Applicant Contact Sam Robertson
Correspondent
Microport Orthopedics
5677 Airline Rd.
Arlington,  TN  38002
Correspondent Contact Sam Robertson
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
HWC   JDI   KWY   KXA   LZN  
LZO   MBL   OQG   OQI  
Date Received01/08/2024
Decision Date 04/18/2024
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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