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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
510(k) Number K253357
Device Name b-ONE® Bipolar Head
Applicant
B-One Ortho, Corp.
3 Wing Dr., Suite 259
Cedar Knolls,  NJ  07927
Applicant Contact Allison Gecik
Correspondent
B-One Ortho, Corp.
3 Wing Dr., Suite 259
Cedar Knolls,  NJ  07927
Correspondent Contact Allison Gecik
Regulation Number888.3390
Classification Product Code
KWY  
Date Received09/30/2025
Decision Date 04/13/2026
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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