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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 K241357
Device Name XT3 System
Applicant
Biodynamik, Inc.
11 Orchard Rd.
Suite 107
Lake Forest,  CA  92630
Applicant Contact Johnny Chen
Correspondent
Biodynamik, Inc.
11 Orchard Rd.
Suite 107
Lake Forest,  CA  92630
Correspondent Contact Johnny Chen
Regulation Number888.3040
Classification Product Code
JDW  
Subsequent Product Code
KTT  
Date Received05/14/2024
Decision Date 01/22/2025
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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