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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nail, Fixation, Bone
510(k) Number K243608
Device Name TRIGEN Stable Lock Nut & Washer
Applicant
Smith & Nephew, Inc.
1450 E. Brooks Rd.
Memphis,  TN  38116
Applicant Contact Jessica Roach
Correspondent
Smith & Nephew, Inc.
1450 E. Brooks Rd.
Memphis,  TN  38116
Correspondent Contact Jessica Roach
Regulation Number888.3030
Classification Product Code
JDS  
Subsequent Product Code
HSB  
Date Received11/22/2024
Decision Date 06/12/2025
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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