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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K241666
Device Name EVOS Pelvic and Acetabular System
Applicant
Smith & Nephew
1450 Brooks Rd.
Memphus,  TN  38116
Applicant Contact Mandy Coe
Correspondent
Smith & Nephew
1450 Brooks Rd.
Memphus,  TN  38116
Correspondent Contact Mandy Coe
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HTN   HWC  
Date Received06/10/2024
Decision Date 02/19/2025
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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