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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 K263116
Device Name OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts
Applicant
OsteoCentric Technologies
75 W 300 N
Suite 150
Logan,  UT  84321
Applicant Contact Stacey Prisbrey
Correspondent
OsteoCentric Technologies
75 W 300 N
Suite 150
Logan,  UT  84321
Correspondent Contact Stacey Prisbrey
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HTN  
Date Received09/04/2026
Decision Date 10/02/2026
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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