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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Threaded
510(k) Number K260073
Device Name XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm
Applicant
Biodynamik, Inc.
11 Orchard
Suite 107
Lake Forest,  CA  92630
Applicant Contact Johnny Chen
Correspondent
Biodynamik, Inc.
11 Orchard
Suite 107
Lake Forest,  CA  92630
Correspondent Contact Johnny Chen
Regulation Number888.3040
Classification Product Code
JDW  
Subsequent Product Code
KTT  
Date Received01/09/2026
Decision Date 02/10/2026
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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