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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 K240061
Device Name TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System
Applicant
Smith & Nephew, Inc.
1450 Brooks Rd.
Memphus,  TN  38116
Applicant Contact Kayla Franklin
Correspondent
Smith & Nephew, Inc.
1450 Brooks Rd.
Memphus,  TN  38116
Correspondent Contact Kayla Franklin
Regulation Number888.3030
Classification Product Code
JDS  
Subsequent Product Codes
HRS   HSB   HWC  
Date Received01/09/2024
Decision Date 09/20/2024
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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