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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K261154
Device Name CoLink® & CoLag® Non-Sterile Screws
Applicant
In2Bones USA, LLC
7750a Trinity Rd.
Cordova,  TN  38018
Applicant Contact Tina Mornak
Correspondent
In2Bones USA, LLC
7750a Trinity Rd.
Cordova,  TN  38018
Correspondent Contact Tina Mornak
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HRS  
Date Received04/08/2026
Decision Date 05/30/2026
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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