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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/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K262473
Device Name NEXUS® Hip Stem
Applicant
Microport Orthopedics, Inc.
5677 Airline Rd.
Arlington,  TN  38002
Applicant Contact Hunter Williams
Correspondent
Microport Orthopedics, Inc.
5677 Airline Rd.
Arlington,  TN  38002
Correspondent Contact Hunter Williams
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Code
MEH  
Date Received07/17/2026
Decision Date 10/01/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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